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International DIPG Registry and Repository CRF Data Abstraction Guide

Update: March 28, 2017

International DIPG Registry and RepositoryCRF Data Abstraction Guide

This manual was developed for the International Diffuse Intrinsic Pontine Glioma (DIPG) Registry and Repository. The material contained in it is solely for assisting data abstraction and entry into the Registry specific case report forms (CRF). Please contact a Registry Coordinator via email: [email protected] or phone: 1-877-349-8074 with any questions or concerns.

GENERAL CONSIDERATIONS

All fields included on the CRFs must be completed and use the common conventions established by this document. Blank or empty fields will not be accepted and are subject to query.

The information documented on the CRFs must be identical to the information found in the corresponding source documentation (e.g., clinic notes, image reports, laboratory results).

Several forms in the CRF set are identified as mandatory (CRFs 1–4) and will need to be included, with all mandatory data fields, when submitting the set of CRFs associated with this Registry.

Forms identified as conditional are only required in the CRF set when needed to document mandatory processes and data (CRFs 5–8) or elements relevant to the science and/or objectives of the protocol. Conditional forms may be completed as many times as necessary if all relevant criteria are met in each instance. CRF 7 (Imaging Assessment) is only completed by Registry approved radiologists and is not included in the CRF booklet provided to sites.

CRFs may be printed and completed on paper or completed electronically if an eCRF version is available. Only a Registry approved eCRF may be completed electronically. Do not complete CRFs intended for paper use electronically as this could result in the loss of information or serious complication within the CRF design. Use a black or blue ink pen only to record study information on the paper CRFs.

COMMON CONVENTIONS

The following are the commonly used conventions and general abstraction guidelines for completing the DIPG Registry’s Case Report Forms:

For the purposes of this Registry and corresponding CRFs, a patient record is considered to be “complete” if a majority of the following pivotal information is intact; demographic information, history and physical exam reports, treatment documentation, radiology and imaging reports, lab results and pathology reports if applicable. If a patient record does not contain 100% of the designated pivotal information; however, contains a reasonable quantity of intact information so that educated and informed assumptions can be made in regards to patient history, it may be considered a “complete” record.

All dates are to be expressed in month/day/year (MMM/DD/YYYY) format (e.g., Jan/01/2015).

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Do not place text where numbers are required unless there is an option to indicate “Unknown”, “Not Applicable”, etc.

Numbers in fields used for age, timelines, weight, etc. should be rounded to the nearest whole number.

When checkboxes are provided for responses, be sure to clearly mark the box with an “X” mark. Make sure the mark is not ambiguous.

Corrections to the paper CRFs must be made in black or blue ink by crossing out the incorrect entry with a single horizontal line, placing the correct information next to the error and providing the initials of the person making the correction and date the correction was made next to the correction. Do not backdate. Do not use any type of correction fluid or tape, and do not erase any entries on the forms.

When completing a free text field avoid the use of abbreviations.

A patient identification number must be documented at the top of each CRF page. A signature (or initials) and date of completion must be provided at the bottom of each CRF page.

A field managed with a positive response, frequently indicated with a “Yes” or other specific data (e.g. image type, radiation type, chemotherapy timing, etc.) must be supported by the corresponding source documentation. Any positive response must be confirmed by the patient record and clearly stated in the patient reports.

An indication of “No” may be used if the patient record clearly states the field in question should be managed as such and is supported by the corresponding source documentation. Any negative response must be confirmed by the patient record and clearly stated in the patient reports. Additionally, if no mention of the field in question is present within a complete record it is assumed to be nonexistent and an indication of “No” is appropriate.

An indication of “Not Applicable” (N/A) may be acceptable for any field in which the content does not apply. Additionally, several fields use “N/A” as a substitute for “No”, “No evidence”, or “No Indication”. If a complete patient record makes no mention of a field in question an indication of “N/A” is appropriate as it is assumed to have not been present if not reported.

An indication of “Unknown” may be acceptable if a significant number of reports are missing from a record so that patient history may not be accurately and confidently assessed. Additionally, if patient status, testing results, and associated dates are unavailable an indication of “Unknown” is also acceptable.

An indication of “Unspecified” may be acceptable if the field in question is confirmed positive; however, sufficient information is not available to confirm a sub-question (e.g. paresis is confirmed by the patient record; however, the side of the body impacted is not available).

CRF 1 –REGISTRATION

1. Referring institution:

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a. Institution where patient received majority of their treatment. 2. Country (e.g. USA, Canada, Australia, China):

a. Location of institution 3. Contact person (MD, parent, coordinator):

a. MD refers to primary treating oncologist at institution or oncologist completing the CRF.

b. List parent or legal guardian’s name if self-referred; if applicable, indicate the individual that signed the consent or HIPAA document.

c. If records are unavailable list the CRA that completed the CRF.4. Patient date of birth (mmm.dd.yyyy):

a. Date of birth (DOB) may be found in patient demographics or face sheet.5. If patient date of birth is unavailable:

a. Select “Unknown”. 6. Patient gender:

a. Sex/gender may be found in patient demographics or face sheet.b. Indicate “Unknown” if information is unavailable.

7. Patient race:a. Race may be found in patient demographics or face sheet.b. Indicate “Unknown” if information is unavailable.c. Indicate “Other” if patient’s race is not listed as an option.

8. Postal code (Patient’s home):a. Home address zip code may be found in patient demographics or face sheet.

9. If international patient or postal code is unavailable: a. Indicate “Unknown” if information is unavailable or record is de-identified.b. Indicate “International” if patient is not from the United States.

10. Time from first presenting symptoms to diagnosis (weeks):a. This information may be assessed in clinic notes and patient history.b. Refers to the extent of time from first observed symptoms to initial diagnosis. c. Initial diagnosis may not be DIPG. d. Time may be a rough estimate. e. Indicate “Unknown” if information is unavailable.

11. If available, specify exact number of weeks from first presenting symptoms to diagnosis:

a. If available, this information should be directly reported in clinic notes and history at time of diagnosis.

b. An age calculator may be used if necessary:i. http://www-users.med.cornell.edu/~spon/picu/calc/convert.htm

12. If exact number of weeks from first presenting symptoms to diagnosis is unavailable

a. Indicate “Unknown” 13. Age at time of diagnosis (months):

a. Use an age calculator to determine patient age in months from date of birth to date of diagnosis.

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b. Initial diagnosis may not be DIPG. c. Patient age should be rounded to nearest whole number if necessary.

i. http://www-users.med.cornell.edu/~spon/picu/calc/agecalc.htm 14. If age at time of diagnosis is unavailable

a. Select “Unknown”15. Weight in kilograms (kg) at time of diagnosis:

a. Patient weight should be assessed in clinic notes and history at time of diagnosis.

b. Patient weight should be rounded to nearest whole number if necessary.c. A weight converter may be used if necessary:

i. http://www-users.med.cornell.edu/~spon/picu/calc/convert.htm 16. If weight in kilograms (kg) at time of diagnosis is unavailable:

a. Select “Unknown” 17. Lansky/Karnofsky score (10-100) at time of diagnosis:

a. Record either the Lanksy or Karnofsky numeric score from the clinic notes at time of radiological diagnosis

18. If Lansky/Karnofsky score is unavailable: a. Select “Unknown”

19. Is the patient alive at time of initial record abstraction?a. Refers to the time at which the patient record is initially abstracted and CRF1 is

completed. b. “Yes” indicates: The patient is alive at time of initial record abstraction. c. “No” indicates: The patient is deceased at time of initial record abstractiond. Indicate “Unknown” If the patient’s status is unknown at time of initial record

abstraction:20. If alive, indicate the date of last contact (mmm.dd.yyyy):

a. Date of last contact refers to the latest available documented interaction with the patient or patient’s family.

b. Date may be assessed from a variety of sources, including but not limited to; clinic notes, phone records, lab records, hospice records, etc.

21. If deceased or date of last contact is unavailable:a. Indicate “N/A” if the patient is deceased. b. Indicate “Unknown” if date of last contact is unavailable.

22. If deceased, indicate the date of death (mmm.dd.yyyy): a. Date may be assessed in death note, final clinic note, autopsy record, or other

various sources. 23. If patient is alive or date of death in unavailable:

a. Indicate “N/A” if the patient is still alive. b. Indicate “Unknown” if the patient is confirmed deceased; however, the actual

date of death cannot be accurately determined. 24. If available, indicate the cause of death:

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a. Cause of death should not be assumed and must be directly stated within documentation and patient record. This may be assessed in death note, final clinic note, autopsy record, etc.

25. If patient is alive or cause of death is unavailable:a. Indicate “N/A” if the patient is still alive. b. Indicate “Unknown” if the patient is confirmed deceased; however, the actual

cause of death cannot be accurately determined. 26. Was an autopsy performed?

a. Indicate “Yes” if autopsy was performed.b. Indicate “No” if autopsy was not performed. c. Indicate “N/A” if patient is still alived. Indicate “Unknown” if it is not known if autopsy was performed

27. Specify tumor histology at autopsy: a. Histology refers to the study of tissues and cells under a microscope. Tumor

histology includes the type of tumor and the grade. The grade is determined by its features, as seen under a microscope and falls into one of four (4) categories: Grade I, Grade II, Grade III, Grade IV. Histology may be found in pathology reports if biopsy or autopsy is performed.

28. If patient is alive or if tumor histology at autopsy is unavailable:a. Indicate “N/A” if the patient is still alive. b. Indicate “Unknown” if autopsy was performed, but the tumor histology is

unavailable

CRF 2 – HISTORY AND PHYSICAL EXAMThe following signs and symptoms were documented in the initial reported patient history:

1. Check all items mentioned in patient history prior to initial physical exam.a. Signs and symptoms are frequently reported by patient’s parents or guardians.b. Multiple items may be applicable; check all that apply. c. Indicate “No” if a complete patient record makes no mention of a sign/symptom

as it is assumed to have not been present if not reported.2. Specify any other signs/symptoms:

a. Include any other relevant physical, mental, and/or behavioral descriptions mentioned in the patient history prior to initial physical exam.

3. Date of initial physical exam (mmm.dd.yyyy):a. Date may be assessed from the initial neurologic exam performed at diagnosis. b. If initial exam is unavailable, use date of physical exam performed nearest to MRI

diagnosis.4. If date of initial physical exam is unavailable:

a. Indicate “Unknown”

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The following signs were present on physical exam at diagnosis:

A confirmation of any of the following signs must be clearly stated in the source documentation and patient record. If the record confirms the patient was positively observed for one of the following signs; however, the side of the body impacted cannot be assessed an indication of “Unspecified” is acceptable. If an assessment cannot be completed due to the patient’s level of cooperation or neurological status indications of “Unknown” is appropriate. Indicate “No” if a complete patient record makes no mention of a sign/symptom as it is assumed to have not been present if not reported.

(L) Left, (R) Right, (LA) Left Arm, (RA) Right Arm, (LL) Left Leg, (RL) Right Leg

5. Ataxia:a. Ataxia describes a lack of muscle coordination during voluntary movements, for

example difficulty walking or picking up objects. A sign of an underlying condition, ataxia can affect your movements, your speech, your eye movements and your ability to swallow.

6. Paresis:a. Paresis- Slight or partial paralysis. A condition typified by a weakness of

voluntary movement, or partial loss of voluntary movement or by impaired movement. When used without qualifiers, it usually refers to the limbs.

7. Hyperreflexia:a. Hyperreflexia is defined as overactive or over-responsive reflexes. Examples of

this can include twitching or spastic tendencies.8. Babinski sign positive:

a. A positive sign is noted when the big toe moves upward toward the surface of the foot and the other toes fan out after the sole of the foot has been firmly stroked. In normal adults the plantar reflex causes a downward response.

9. Papilledema:a. Papilledema is categorized as swelling of the head of the optic nerve and may be

a sign of increased intracranial pressure.10. Hemiplegia:

a. Hemiplegia is paralysis of the arm, leg, and trunk on the same side of the body.11. Monoplegia:

a. Monoplegia is a paralysis of a single limb, usually an arm.12. Quadriplegia:

a. Quadriplegia is paralysis that results in the partial or total loss of use of all limbs and torso.

13. Dysmetria:

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a. Dysmetria refers to a lack of coordination of movement typified by the undershoot or overshoot of intended position with the hand, arm, leg, or eye. It is sometimes described as an inability to judge distance or scale.

14. Diplopia:a. Diplopia is commonly known as double vision.

15. Cranial nerve palsy II:a. Indicate only if a nerve palsy II is confirmed in the patient record.

16. Cranial nerve palsy III:a. Indicate only if a nerve palsy III confirmed in the patient record.

17. Cranial nerve palsy IV:a. Indicate only if a nerve palsy IV confirmed in the patient record.

18. Cranial nerve palsy V:a. Indicate only if a nerve palsy V confirmed in the patient record.

19. Cranial nerve palsy VI:a. Indicate only if a nerve palsy VI confirmed in the patient record.

20. Cranial nerve palsy VII:a. Indicate only if a nerve palsy VII confirmed in the patient record.

21. Cranial nerve palsy VIII:a. Indicate only if a nerve palsy VII confirmed in the patient record.

22. Cranial nerve palsy IX:a. Indicate only if a nerve palsy IX confirmed in the patient record.

23. Cranial nerve palsy X:a. Indicate only if a nerve palsy X confirmed in the patient record.

24. Cranial nerve palsy XI:a. Indicate only if a nerve palsy XI confirmed in the patient record.

25. Cranial nerve palsy XII:a. Indicate only if a nerve palsy XII confirmed in the patient record.

26. Nystagmusa. Nystagmus is a vision condition in which the eyes make repetitive, uncontrolled

movements. These movements often result in reduced vision and depth perception and can affect balance and coordination.

27. Specify any other findings:a. Describe any other relevant findings. b. Indicate NA if nothing additional is relevant to mention.

– PATIENT MEDICAL HISTORY –

28. Multiple birth (e.g. twin, triplet):a. Indicate “Yes” only if the record confirms the patient was part of a multiple birth.b. Indicate “No” if the record confirms patient was not a multiple birth or if no

mention of multiple birth is present within a complete record.

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c. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

29. Pre-existent genetic condition(s):a. Pre-existent refers to any time prior to the onset of signs/symptoms.b. Indicate “Yes” only if a pre-existent genetic condition(s) is confirmed in the

patient record. c. Indicate “No” if the patient record confirms there are no other pre-existent genetic

conditions or if no mention of pre-existent genetic conditions is present within a complete record.

d. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

30. If yes, please specify:a. Specify condition and any additional relevant information.b. Indicate NA if no pre-existent genetic conditions

31. Pre-existent psychological / behavioral condition(s):a. Pre-existent refers to any time prior to the onset of symptoms.b. Indicate “Yes” only if a pre-existent psychological / behavioral condition(s) is

confirmed in the patient record. c. Indicate “No” if the patient record confirms there are no pre-existent

psychological/behavioral conditions or if no mention of pre-existent psychological or behavioral conditions is present within a complete record.

a. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

32. If yes, please specify:a. Specify any other pre-existent conditions, behaviors, or mental health concerns

stated in the patient record. b. Indicate NA if no pre-existent psychological / behavioral condition(s)

33. Other pre-existent condition(s):a. Pre-existent refers to any time prior to the onset of symptoms.b. Indicate “Yes” only if confirmed in the patient record. c. Include any additional conditions mentioned in the patient’s medical history not

addressed by the previous sections. d. Indicate “No” if the patient record confirms there are no other pre-existent

conditions or if no mention of other pre-existent conditions is present within a complete record.

e. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

34. If yes, please specify:a. Specify any additional conditions or other relevant information. b. Indicate NA if no additional condition(s)

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– FAMILY MEDICAL HISTORY –

35. Pre-existent genetic condition(s):a. Pre-existent refers to any time prior to the onset of symptoms.b. Indicate “Yes” only if confirmed in the patient record. c. Include any additional genetic conditions mentioned in the patient’s family

medical history not addressed by the following sections. d. Indicate “No” if the patient record confirms there are no other pre-existent

conditions within the family or if no mention of other pre-existent conditions is present within a complete record.


36. If yes, please specify:a. If applicable/available, specify all genetic conditions by individual family

members.b. Indicate NA if no pre-existent genetic condition(s)

37. Cancer in the immediate family:a. Indicate “Yes” only if directly stated in the patient record.b. Indicate “No” if the patient record states there are is no cancer history within the

family or if no mention of cancer history is present within a complete record it is assumed to they do not exist.


38. If yes, please specify:a. Specify all cancer by individual family members by type and age if available.b. Indicate NA if no cancer in the immediate family

39. Consanguinity:a. Indicate “Yes” only if inbreeding within the family is confirmed in the patient

record. b. Indicate “No” if the patient record states there is no history of inbreeding within

the family or if no mention of inbreeding is present within a complete record. c. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 40. If yes, please specify:

a. Specify individuals and relationship to the patient. b. Indicate NA if no consanguinity

41. Other pre-existent condition(s):a. Pre-existent refers to any time prior to the onset of symptoms.b. Indicate “Yes” only if directly stated in the patient record. c. Include any additional conditions mentioned in the family’s medical history not

addressed by the previous sections.

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d. Indicate “No” if the patient record states there are no other pre-existent conditions or if no mention of other pre-existent conditions is present within a complete record it is assumed to they do not exist.


42. If yes, please specify:a. Specify any additional conditions or other information.b. Indicate NA if no other pre-existent condition(s)

CRF 3 – DIAGNOSIS AND IMAGING

1. Date of initial radiological diagnosis (MRI/CT) (mmm.dd.yyyy):a. Refers to date of initial imaging diagnosis via MRI/CT that indicates the confirmed

presence of a lesion.b. Found in the imaging reports and clinic notes. c. Initial diagnosis may not be DIPG.

2. If date of initial radiological diagnosis is unavailable:a. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”.

– MRI BRAIN –

3. Was a MRI of the brain completed at diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” if MRI record is on file or there is a report of an MRI procedure in the

clinic notes at the time of diagnosis.d. Indicate “No” if no record exists that a MRI was collected during diagnosis or a CT

was collected instead. e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 4. Date of MRI (mmm.dd.yyyy):

a. Found in MRI report or clinic note.5. If brain MRI was not performed or date is unavailable:

a. Indicate “Unknown” if record confirms a MRI was completed at time of diagnosis; however, there is no date associated with the report.

b. Indicate “N/A” if MRI was not performed.

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– MRI SPINE –

6. Was a spine MRI completed at diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” if spine MRI record is on file or there is a report of a spine MRI

procedure in the clinic notes at the time of diagnosis.d. Indicate “No” if no record exists that a spine MRI was collected during diagnosis or a

CT was instead. e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 7. Date of spine MRI (mmm.dd.yyyy):

a. Found in spine MRI report or clinic note.8. If spine MRI was not performed or date is unavailable:

a. Indicate “N/A” if spine MRI was not performed. b. Indicate “Unknown” if record confirms a spine MRI was completed at time of

diagnosis; however, there is no date associated with the report. 9. Did the MRI report state evidence of disease in the spine?

a. Spine MRI report will state if spine is positive for disease.b. Indicate “Yes” if report states there is evidence of disease. c. Indicate “No” if report states there is no evidence of disease.d. Indicate “N/A” if spine MRI was not performed. e. Indicate “Unknown” if the record confirms a spine MRI was performed; however, the

report and results are unavailable.

– MR SPECTROSCOPY –

10. Was MR spectroscopy completed at diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” if MRS record is on file or there is a report of a MRS procedure in the

clinic notes at the time of diagnosis.d. Indicate “No” if no record exists that a MRS was collected during diagnosis.e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 11. Date of MR spectroscopy (mmm.dd.yyyy):

a. Found in MRS report or clinic note.12. If MR spectroscopy was not performed or date is unavailable:

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a. Indicate “N/A” if MRS was not performed. b. Indicate “Unknown” if record confirms a MRS was completed at time of diagnosis;

however, there is no date associated with the report.

– PET IMAGING –

13. Was a PET completed at diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” if PET record is on file or there is a report of a PET procedure in the

clinic notes at the time of diagnosis.d. Indicate “No” if no record exists that a PET was collected during diagnosis.e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 14. Date of PET (mmm.dd.yyyy):

a. Found in PET report or clinic note.15. If PET was not performed or date is unavailable:

a. Indicate “N/A” if PET was not performed. b. Indicate “Unknown” if record confirms a PET was completed at time of diagnosis;


– CT SCAN –

16. Was a CT completed at diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” if CT record is on file or there is a report of a CT procedure in the clinic

notes at the time of diagnosis.d. Indicate “No” if no record exists that a CT was collected during diagnosis or a MRI

was collected instead. e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 17. Date of CT (mmm.dd.yyyy):

a. Found in CT report or clinic note.18. If CT was not performed or date is unavailable:

a. Indicate “N/A” if CT was not performed. b. Indicate “Unknown” if record states a CT was completed at time of diagnosis;


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– HYDROCEPHALUS –

19. Was hydrocephalus reported at time of diagnosis?a. Refers to date of initial diagnosis. b. Initial diagnosis may not be DIPG. c. Indicate “Yes” only if the patient record states hydrocephalus was observed at time

of diagnosis. d. Indicate “No” if record states no evidence of hydrocephalus or record does not

mention hydrocephalus. Assumed not present if no mention exists in patient record. e. Indicate “Unknown” if there is a report of hydrocephalus; however, there is no date

associated with the report. f. If a significant number of reports are missing from a record so that patient history


– BIOPSY –

20. Did the patient ever have a biopsy performed?a. May be found in pathology or operative notes. If pathology is unavailable, clinic notes

may be used. b. Indicate “Yes” if the patient ever had a biopsy at any time.c. Indicate “No” if patient did not have a biopsy. Additionally, if no mention of a biopsy is

available within a complete record it is assumed to have not been performed. Indicate “

d. Unknown” if a significant number of reports are missing from a record so that patient history may not be assessed.

21. Was patient’s diagnosis confirmed by biopsy?a. May be found in pathology or operative notes. If pathology is unavailable, clinic notes

may be used. b. Indicate “Yes” if the patient record states that diagnosis was confirmed by biopsy. c. Indicate “No” if the patient record states a biopsy was not performed or if a

performed biopsy was not diagnostic. Additionally, if no mention of a biopsy is available within a complete record it is assumed to have not been performed.

d. Indicate “Unknown” if a significant number of reports are missing from a record so that patient history may not be assessed.

22. Location of biopsies:a. Found in operative, pathology, or clinic notes

23. If initial biopsy was not performed or results are unavailable:a. Indicate “N/A” if a biopsy was not performed.

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b. Indicate “Unknown” if record confirms a biopsy was performed; however the results are unavailable.

24. Number of biopsies:a. Indicate the total number of samples collected during biopsy.b. Found in operative, pathology, or clinic notes.

25. If initial biopsy was not performed or results are unavailable:a. Indicate “N/A” if a biopsy was not performed. b. Indicate “Unknown” if record confirms a biopsy was performed; however the intent

and/or results are unavailable. 26. Pathologic diagnosis:

a. Specify the confirmed diagnosis. b. May be found in pathology report of biopsy or in clinic notes.

27. Pathologic diagnosis is not obtained or unavailable:a. Indicate “N/A” if a biopsy was not performed. b. Indicate “Unknown” if record confirms a biopsy was performed; however the intent

and/or results are unavailable.

– RE-BIOPSY –

28. Was the patient re-biopsied?a. May be found in pathology or operative notes. If pathology is unavailable, clinic notes

may be used. b. Indicate “Yes” if the patient was re-biopsied. c. Indicate “No” if patient was not re-biopsied. Additionally, if no mention of a re-biopsy

is available within a complete record it is assumed to have not been performed. d. Indicate “Unknown” if a significant number of reports are missing from a record so

that patient history may not be assessed.29. Location of biopsies:

a. Found in operative, pathology, or clinic notes30. If biopsy was not performed or results are unavailable:

a. Indicate “N/A” if a biopsy was not performed. b. Indicate “Unknown” if record confirms a biopsy was performed; however the results

are unavailable.

31. Number of biopsies:a. Indicate the total number of samples collected during biopsy.b. Found in operative, pathology, or clinic notes.

32. If biopsy was not performed or results are unavailable:a. Indicate “N/A” if a biopsy was not performed. b. Indicate “Unknown” if record confirms a biopsy was performed; however the intent

and/or results are unavailable. 33. Pathologic diagnosis:

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a. Specify the confirmed diagnosis. b. May be found in pathology report of biopsy or in clinic notes.

34. Pathologic diagnosis obtained or unavailable:a. Indicate “N/A” if a biopsy was not performed. b. Indicate “Unknown” if record confirms a biopsy was performed; however the intent

and/or results are unavailable.

– CEREBROSPINAL FLUID (CSF) –

35. Was CSF cytology completed at time of diagnosis?a. Cytologic evaluation of cerebrospinal fluid (CSF) is an effective means for diagnosing

many disorders involving the central nervous system (CNS).b. Indicate “Yes” if the patient record states that CSF was collected at the time of

diagnosis. c. Indicate “No” if the record confirms CSF was not collected, CSF was collected but

not at diagnosis, or if there is no mention of a procedure in the patient record. If there is no mention within a complete record it is assumed to have not been performed.

d. Indicate “Unknown” if the record confirms a procedure; however, there is no date associated with the collection that can be linked to time of diagnosis.


36. Site of fluid collection:a. The site of fluid collection will be directly stated in the pathology report, lab or clinic

notes.b. There are different ways to get a sample of CSF. Lumbar puncture (spinal tap) is the

most common method. CSF may also be collected from a tube that's already placed in the fluid, such as a shunt or a ventricular drain.

c. Indicate “Lumbar” if collection was performed by lumbar puncture (LP). d. Indicate “Ventricular” if collection taken from a shunt or a ventricular drain.e. Indicate “Unknown” if there is a record of collection; however, no site associated with

the collection. f. Indicate “N/A” if CSF was not collected at the time of diagnosis.

37. If CSF was collected, was the sample positive for tumor cells?a. Pertains only to the CSF collection at time of diagnosis. b. Will be directly stated in the pathology report, lab or clinic notes.c. Indicate “Yes” if the patient record states that CSF was positive for tumor cells or

disease at the time of diagnosis. d. Indicate “No” if the record confirms CSF was not positive for tumor cells/disease or if

there is no mention of tumor cells/disease in the patient record. If there is no mention within a complete record it is assumed to have been negative.

e. Indicate “Unknown” if record confirms CSF was collected; however the results are unavailable.

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f. Indicate “N/A” if CSF was not collected at the time of diagnosis.

CRF 4 – TREATMENT

1. Did the patient undergo surgical intervention?a. May be found in pathology, operative or clinic notes. b. Indicate “Yes” only if the patient record states brain specific surgery was

performed. c. Indicate “No” if the patient record states no surgery was performed or if the

patient record shows no evidence of brain specific surgery. Assumed to have not been performed if no report is available within a complete record.

d. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

2. Date of surgery (mmm.dd.yyyy):a. Refers to the date surgery was performed.b. May be found in pathology, operative or clinic notes.

3. If surgery was not performed or date is unavailable:a. Indicate “Unknown” if record confirms a surgical procedure was performed;

however, there is no date associated with the report.b. Indicate “N/A” if patient did not undergo surgical intervention.

4. Type of surgery:a. May be found in pathology, operative or clinic notes. b. Specify only if confirmed in patient record (e.g. shunt, biopsy, resection, etc.).

5. If surgery was not performed or type is unavailable:a. Indicate “Unknown” if record confirms a surgical procedure was performed;

however, there is no type specified with the report.b. Indicate “N/A” if patient did not undergo surgical intervention.

6. Please state the degree of resection: a. Refers to the removal of tissue from a patient’s brain via surgical procedure.

Degree of resection refers to the estimated percentage or amount of tumor removed.

b. May be found in pathology, operative or clinic notes. c. Indicate “None” if surgery was performed; however, no tissue was resected.d. Indicate percentage of resection only if it can be confirmed within the patient

record. e. Indicate “Other” if the percentage of resection does not fall within the ranges

designated within this Case Report Form.

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f. Indicate “Unknown” if the record confirms that resection occurred; however the percentage of resection is unavailable.

g. Indicate “N/A” if patient did not undergo surgical intervention.7. If other, please comment:

a. Other refers to any degree or percentage of resection not within ranges designated by this Case Report Form. Please add any additional information necessary.

8. Surgical comments:a. Please add any additional information necessary regarding the surgery.

– Additional Surgeries –

9. Date of surgery (mmm.dd.yyyy):a. Refers to the date surgery was performed.b. May be found in pathology, operative or clinic notes.

10. If surgery was not performed or type is unavailable:c. Indicate “Unknown” if record confirms a surgical procedure was performed;

however, there is no date associated with the report.d. Indicate “N/A” if patient did not undergo surgical intervention.

11. Type of surgery:a. May be found in pathology, operative or clinic notes. b. Specify only if confirmed in patient record (e.g. shunt, biopsy, resection, etc.).

12. If surgery was not performed or date is unavailable:c. Indicate “Unknown” if record confirms a surgical procedure was performed;

however, there is no type specified with the report.d. Indicate “N/A” if patient did not undergo surgical intervention.

13. Please state the degree of resection: a. Refers to the removal of tissue from a patient’s brain via surgical procedure.

Degree of resection refers to the estimated percentage or amount of tumor removed.

b. May be found in pathology, operative or clinic notes. c. Indicate “None” if surgery was performed; however, no tissue was resected.d. Indicate percentage of resection only if it can be confirmed within the patient

record. e. Indicate “Other” if the percentage of resection does not fall within the ranges

designated within this Case Report Form.f. Indicate “Unknown” if the record confirms that resection occurred; however the

percentage of resection is unavailable. g. Indicate “N/A” if patient did not undergo surgical intervention.

14. If other, please comment:a. Other refers to any degree or percentage of resection not within ranges

designated by this Case Report Form. Please add any additional information necessary.

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15. Comments:a. Please add any additional information necessary regarding the surgery.

16. Did the patient ever present with hydrocephalus?a. Refers to the presentation of hydrocephalus at any point in the patient record. b. May be found in clinic notes, imaging, pathology, or operative reports. c. Indicate “Yes” if a report clearly confirms that the patient presented with

hydrocephalus. d. Indicate “No” if the report confirms the patient did not present with hydrocephalus

or there is no mention of hydrocephalus in a patient record. Assumed to have not been present if no mention is available in a complete record.


17. Did the patient ever undergo a CSF diversion?a. If the patient record confirms a procedure was performed to drain fluid from the

brain by means of surgical intervention to address hydrocephalus select the type of procedure completed. This may be available in the operative reports, imaging reports, clinic notes, etc.

b. Indicate “No” if the record confirms no procedure was performed or if the patient record shows no evidence of a procedure. Assumed to have not been performed if no report is available in a complete record.

c. If a surgical procedure was performed; however, the type of procedure is unavailable select “Unknown”.

18. If other, please comment:a. Specify any other type of diversion procedure not listed by this Case Report

Form.19. Was CSF cytology completed any time after diagnosis?

a. Indicate “Yes” if CSF cytology was collected any time after diagnosis b. Indicate “No” If CSF cytology was completed at diagnosis or was not completedc. Indicate “Unknown” if a significant number of reports are missing from a record

so that patient history may not be assessed20. Site of fluid collection:

a. Pertains only to the CSF collection after diagnosis. The site of fluid collection will be directly stated in the pathology report, lab or clinic notes. There are different ways to get a sample of CSF. Lumbar puncture (spinal tap) is the most common method. CSF may also be collected from a tube that's already placed in the fluid, such as a shunt or a ventricular drain.

b. Indicate “Lumbar” if collection was performed by lumbar puncture (LP). c. Indicate “Ventricular” if collection taken from a shunt or a ventricular drain. d. Indicate “Unknown” if there is a record of collection; however, no site associated

with the collection. e. Indicate “N/A” if CSF was not collected after diagnosis.

21. If CSF was collected, was the sample positive for tumor cells?

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a. Pertains only to the CSF collection after diagnosis. Will be directly stated in the pathology report, lab or clinic notes.

b. Indicate “Yes” if the patient record states that CSF was positive for tumor cells or disease at the time of diagnosis.

c. Indicate “No” if the record confirms CSF was not positive for tumor cells/disease or if there is no mention of tumor cells/disease in the patient record. If there is no mention within a complete record it is assumed to have been negative.

d. Indicate “Unknown” if record confirms CSF was collected; however the results are unavailable.

e. Indicate “N/A” if CSF was not collected after diagnosis.

– STEROIDS –

22. Did the patient ever receive steroids?a. This question examines if the patient ever received steroids in any amount

throughout the course of treatment. b. May be found in clinic notes, treatment section, etc. c. Indicate “Yes” if a report clearly confirms that the patient was treated with

steroids. d. Indicate “No” if the report confirms the patient was not treated with steroids or

there is no mention of steroid use in a patient record. Assumed to have not been used if no mention is available in a complete record.


23. Did the patient receive steroids during radiation? a. Indicate “Yes” if patient received steroids at any point during radiotherapy. b. Indicate “No” if patient did not receive steroids at any point during radiotherapy.c. Indicate “Unknown” if a significant number of reports are missing from a record

so that patient history may not be assessed.

If steroids were used during initial radiotherapy, indicate dates received and start of taper:

24A. Steroid Start (mmm.dd.yyyy):a. Refers to the date that a steroid regimen was started. b. Regimen must have been initiated before or during radiotherapy to be applicable.

25A. If patient did not receive steroids during radiotherapy or start date is unavailable:

a. Indicate “Unknown” if the record confirms that steroids were taken during radiotherapy; however, no start date is evident.

b. Indicate “N/A” if the patient did not receive steroids during radiotherapy.

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26A. Steroid Stop (mmm.dd.yyyy):a. Refers to the date that a steroid regimen was competed. b. Regimen must have been started before or during radiotherapy to be applicable.

27A. If patient did not receive steroids during radiotherapy or stop date is unavailable:

a. Indicate “Unknown” if the record confirms that steroids were taken during radiotherapy; however, no completion date is evident.

b. Indicate “N/A” if the patient did not receive steroids during radiotherapy. 28A. Taper Started:

a. This question refers to the date that a steroid regimen taper began. Tapering refers to the gradual decrease of steroids given to a patient.

b. A taper must have been started during radiotherapy to be applicable.c. Must compare radiation therapy timeline with steroid record to determine when

taper began. d. Full taper does not have to be completed to be applicable. e. Indicate “Never” if patient received steroids during radiotherapy; however, no

intent to taper ever occurred. f. Indicate “Unknown” if the record states that there was intent to taper steroids

during radiotherapy; however, taper cannot be confirmed. g. Indicate “N/A” if the patient did not receive steroids during radiotherapy.

If steroids were used during reirradiation, indicate dates received and start of taper:

24B. Steroid Start (mmm.dd.yyyy):a. Refers to the date that a steroid regimen started. b. Regimen must have been started before or during reirradiation to be applicable.

25B. If patient did not receive steroids during radiotherapy or start date is unavailable:

a. Indicate “Unknown” if the record confirms that steroids were taken during reirradiation; however, no start date is evident.

b. Indicate “N/A” if the patient did not receive steroids during reirradiation or the patient was not reirradiated.

26B. Steroid Stop (mmm.dd.yyyy):a. Refers to the date that a steroid regimen was competed. b. Regimen must have been started before or during reirradiation to be applicable.

27B. If patient did not receive steroids during radiotherapy or stop date is unavailable:

a. Indicate “Unknown” if the record states that steroids were taken during reirradiation; however, completion date cannot be confirmed.

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b. Indicate “N/A” if the patient did not receive steroids during radiotherapy or the patient was not reirradiated.

28B. Taper Started:a. This question refers to the date that a steroid regimen taper began. Tapering

refers to the gradual decrease of steroids given to a patient. b. A taper must have been started during reirradiation to be applicable.c. Must compare radiation therapy timeline with steroid record to determine when

taper began. d. Full taper does not have to be completed to be applicable. e. Indicate “Never” if patient received steroids during reirradiation; however, no

intent to taper ever occurred. f. Indicate “Unknown” if the record states that there was intent to taper steroids

during reirradiation; however, taper cannot be confirmed. g. Indicate “N/A” if the patient did not receive steroids during reirradiation or the

patient was not reirradiated. 29. Was steroid regimen received during reirradiation:

a. This question examines if the patient ever received steroids in any amount throughout the course of reirradiation.

b. May be found in clinic notes, treatment section, etc. c. Indicate “Yes” if a report clearly confirms that the patient was treated with

steroids during reirradiation. d. Indicate “No” if the report confirms the patient was not treated with steroids or

there is no mention of steroid use in a patient record. Assumed to have not been used if no mention is available in a complete record.

e. Indicate “N/A” if the patient was never reirradiated. f. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 30. Were steroids used palliatively during the final four (4) weeks of life?

a. Palliative care focuses on providing patients with relief from symptoms, pain, and stress, but not curative treatment.

b. This question refers to the use of steroids for any reason during the final four (4) weeks of a patient’s life.

c. Indicate “Yes” if the record confirms that steroids were received during the final four (4) weeks of patient’s life.

d. Indicate “No” if the record confirms that steroids were not received during the final four weeks of patient’s life or there is no evidence of steroid use during that time.

e. Indicate “Unknown” if steroids were received during treatment; however, the dates of use cannot be accurately determined.

– RADIATION –

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31. Was the patient treated with radiotherapy?a. Refers to radiotherapy in any amount throughout the course of treatment. b. Examine clinic notes for any mention of radiation (RT, RTx, XRT) and/or a

protocol regimen that includes radiation as treatment.c. Indicate “Yes” if the record confirms radiation was used as treatment. d. Indicate “No” if the record confirms radiation was not used or no radiation is

mentioned in a complete record. e. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 32. Specify the type of radiation received:

a. Specify radiation type only if confirmed by the patient record. b. Normofractionated radiation is divided into normal doses. The conventional dose

of radiation ranges between 54 Gy and 60 Gy given locally to the primary tumor site in single daily fractions. This is considered standard of care. (e.g. 54 Gy in single doses of 1.8 Gy given once daily over 6 weeks).

c. Hypofractionated radiation is divided into large doses; not given daily. Typically provided over 3 to 4 weeks.

d. Hyperfractionated radiation is divided into small doses and treatments that are given more than once a day. Patients receive higher doses of radiation (e.g.70.2 Gy) over 6 weeks.

e. Examine clinic notes for any mention of radiation (RT, RTx, XRT) and/or a protocol regimen that includes radiation as treatment.

f. Indicate “Unknown” if radiation was received during treatment; however, the type of radiation cannot be accurately determined.

f. Indicate “Unknown” if question #31 CRF4 was answered “Unknown”. g. Select “N/A” if the patient did not receive radiation during treatment.

33. Specify the modality of radiation received:a. Specify radiation modality only if confirmed by the patient record.

34. If patient did not receive radiation or modality is unavailable: a. Select “N/A” if the patient did not receive radiation during treatmentb. Indicate “Unknown” if radiation was received during treatment; however, the

modality of radiation cannot be accurately determined. 35. Indicate the date radiation started (mmm.dd.yyyy):

a. Refers to the date that a radiation regimen started. 36. If patient did not receive radiation or start date is unavailable:

a. Indicate “N/A” if the patient did not receive radiation. b. Indicate “Unknown” if the record confirms that radiation was received; however,

no start date is evident. 37. Indicate the date radiation completed (mmm.dd.yyyy):

a. Refers to the date that a radiation regimen was completed. b. Add six weeks, 42 days, to start date to estimate approximate end date if

unavailable.

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38. If patient did not receive radiation or stop date is unavailable: a. Indicate “N/A” if the patient did not receive radiation. b. Indicate “Unknown” if the record states that radiation was received; however, no

completion date is evident. 39. Total dose of radiation:

a. Total Dose is indicated Gy (gray)(e.g. 54 Gy).b. This information may be found in clinic and treatment notes. c. If applicable a protocol may provide specifics if not found in the patient record.

i. https://clinicaltrials.gov/ 40. If patient did not receive radiation or dose is unavailable:

a. Indicate “N/A” if the patient did not receive radiation. b. Select “Unknown” if the record states that radiation was received; however, no

amount is evident. 41. Fractions:

a. The total dose of radiation is divided into fractions (amount given in a single administration), (e.g. 60 Gy in 1.8 - 2 Gy fractions).

b. This information may be found in clinic and treatment notes. c. If applicable a protocol may provide specifics if not found in the patient record.

i. https://clinicaltrials.gov/ 42. If patient did not receive radiation or dose is unavailable:

a. Indicate “N/A” if the patient did not receive radiation. b. Select “Unknown” if the record states that radiation was received; however, no

amount is evident. 43. Did the patient receive local radiation only?

a. Local radiation refers to radiation limited to a specific area. b. If not confirmed by the patient record, assume radiation is local or focal as this is

the current standard of care.c. Indicate “N/A” if the patient did not receive radiation. d. Indicate “Unknown” if question #12 CRF4 was answered “Unknown”.

Only complete questions 44 – 55 if patient was reirradiated

44. Was the patient reirradiated?a. Re-irradiation is defined as repeat administration of radiotherapy to a previously

exposed region of the body.b. Refers to reirradiation in any amount throughout the course of treatment. c. Examine clinic notes for any mention of reirradiation (RT, RTx, XRT) and/or a

protocol regimen that includes reirradiation as treatment.d. Indicate “Yes” if the record confirms reirradiation was performed. e. Indicate “No” if the record states reirradiation was not performed or reirradiation

is not mentioned in a complete record.

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https://clinicaltrials.gov/




f. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

45. If reirradiated, specify the type of radiation received:a. Indicate radiation type only if stated within the patient record. b. Normofractionated radiation is divided into normal doses. The conventional dose

of radiation ranges between 54 Gy and 60 Gy given locally to the primary tumor site in single daily fractions. This is considered standard of care. (e.g. 54 Gy in single doses of 1.8 Gy given once daily over 6 weeks).

c. Hypofractionated radiation is divided into large doses; not given daily. Typically provided over 3 to 4 weeks.

d. Hyperfractionated radiation is divided into small doses and treatments that are given more than once a day. Patients receive higher doses of radiation (e.g.70.2 Gy) over 6 weeks.

e. Indicate “N/A” if the patient did not receive radiation during treatment.f. Indicate “Unknown” if radiation was received during treatment; however, the

round of radiation cannot be accurately determined. g. Indicate “Unknown” if question #31 CRF4 was answered “Unknown”.

46. If reirradiated, indicate the date radiation started:a. Refers to the date that a reirradiation regimen started.

47. If patient was not reirradiated or date is unavailable: a. Indicate “N/A” if the patient did not receive reirradiation. b. Select “Unknown” if the record states that reirradiation was received; however,

no start date is evident. 48. If reirradiated, indicate the date completed:

a. Refers to the date that a reirradiation regimen was completed. 49. If patient was not reirradiated or date is unavailable:

a. Indicate “N/A” if the patient did not receive reirradiation.b. Select “Unknown” if the record confirms that reirradiation was received; however,

no completion date is evident. 50. If reirradiated, indicate the total dose of radiation:

a. Total Dose is indicated Gy (gray)(e.g. 54 Gy).b. This information may be found in clinic and treatment notes. c. If applicable a protocol may provide specifics if not found in the patient record.

i. https://clinicaltrials.gov/ 51. If patient was not reirradiated or dose is unavailable:

a. Indicate “N/A” if the patient did not receive reirradiation. b. Select “Unknown” if the record confirms that reirradiation was received; however,

no amount is evident. 52. If reirradiated, indicate the fractions:

a. The total dose of radiation is divided into fractions (amount given in a single administration), (e.g. 60 Gy in 1.8 - 2 Gy fractions).

b. This information may be found in clinic and treatment notes. c. If applicable a protocol may provide specifics if not found in the patient record.

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i. https://clinicaltrials.gov/ 53. If patient was not reirradiated or dose is unavailable:

a. Indicate “N/A” if the patient did not receive reirradiation. b. Select “Unknown” if the record confirms that reirradiation was received; however,

no amount is evident. 54. If reirradiated, did the patient receive local radiation only?

a. Local radiation refers to radiation limited to a specific area. b. If not directly stated in the patient record, assume radiation is local or focal as

this is the current standard of care.c. Indicate “N/A” if the patient did not receive reirradiation.

55. If reirradiated, did the patient receive craniospinal radiation?a. Craniospinal refers to radiation given to the whole brain and spinal cord. b. Select “Yes” only if craniospinal radiation is stated in the patient record. c. Indicate “No” if the record states craniospinal was not performed or craniospinal

is not mentioned in a complete record. d. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. e. Indicate “Unknown” if question #31 CRF4 was answered “Unknown”. f. Indicate “N/A” if the patient did not receive reirradiation.

– CHEMOTHERAPY –

56. Was the patient treated with chemotherapy?a. Examine to labs, clinic notes, treatment notes, and notes on clinical protocols to

determine if the patient received chemotherapy (e.g. CH, CMT, CTX, CRT) at any point during treatment.

b. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

If patient was treated with chemotherapy, please specify the regimen details below:

57. Dosage:a. Depending on the drug(s) to be given, there are different ways to determine

chemotherapy doses. Most chemotherapy drugs are measured in milligrams (mg).

b. The overall dose may be based on a person’s body weight in kilograms (1 kilogram is 2.2 pounds). For instance, if the standard dose of a drug is 10 milligrams per kilogram (10 mg/kg), a person weighing 110 pounds (50 kilograms) would receive 500 mg (10 mg/kg x 50 kg).

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c. Some chemotherapy doses are determined based on body surface area (BSA), which doctors calculate using your height and weight. BSA is expressed in meters squared (m2).

d. Examine clinic and treatment notes for any mention of chemotherapy used as treatment to determine the dosage for a given chemotherapy regimen.

e. If applicable a protocol may provide specifics if not found in the patient record. i. https://clinicaltrials.gov/

58. If patient did not receive chemotherapy or dosage is unavailable: f. Indicate “Unknown” if the record confirms that chemotherapy was received;

however, no dosage is evident. 59. Cycles:

a. Chemotherapy may repeat weekly, bi-weekly, or monthly. Usually, a cycle is defined in monthly intervals. For example, two bi-weekly chemotherapy sessions may be classified as one cycle.

b. In most cases, the number of cycles - or the length of chemotherapy from start to finish - has been determined by research and clinical trials.

c. Examine clinic and treatment notes for any mention of chemotherapy used as treatment to determine the number of cycles for a given chemotherapy regimen.

d. If applicable a protocol may provide specifics if not found in the patient record. i. https://clinicaltrials.gov/

60. If patient did not receive chemotherapy or cycles are unavailable: e. Indicate “Unknown” if the record confirms that chemotherapy was received;

however, no cycle is evident. 61. Start:

a. Refers to the date that a chemotherapy regimen started. 62. If patient did not receive chemotherapy or start date is unavailable:

b. Indicate “Unknown” if the record confirms that chemotherapy was received; however, no start date is evident.

c. Indicate “N/A” if the patient did not receive chemotherapy. 63. Stop:

a. Refers to the date that a chemotherapy regimen was completed. 64. If patient did not receive chemotherapy or stop date is unavailable:

b. Indicate “Unknown” if the record confirms that chemotherapy was received; however, no completion date is evident.

c. Indicate “N/A” if the patient did not receive chemotherapy. 65. Regimen/protocol:

a. Refers to the treatment procedures used in a clinical trial.66. If patient did not receive chemotherapy or Regimen/protocol is unavailable:

b. Specify protocol name. If not part of clinical trial indicate name of drug in use. c. Indicate “Unknown” if the record confirms that chemotherapy was received;

however, no protocol or drug name is available. 67. Timing:

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a. Timing” refers to the point at which chemotherapy was provided in relation to the timing of other methods of treatment, as well as stage of disease in relation to stages of treatment. Multiple boxes may be checked.

b. Indicate “Neoadjuvant” if chemotherapy is given before primary therapy. c. Indicate “During RT” (radiation) if chemotherapy is given in conjunction with

radiotherapy. d. Indicate “Adjuvant” if chemotherapy is given after primary therapy. e. Indicate “Refractory” if chemotherapy is provided as treatment to disease that

has not responded or has become resistant to treatment. f. Indicate “First Progression” if chemotherapy is given in response to the first

progression.g. Indicate “Subsequent progression” if chemotherapy is given in response to any

progression after first progression. h. Indicate “Progression timing unspecified” if it is known that chemotherapy is

given in response to progression, but progression timing cannot be determined. i. Indicate “Unknown” if the record states that chemotherapy was received;

however, not enough information exists in the patient record to determine timing. 68. On schedule:

a. “On schedule” refers to adherence to the treatment schedule according to the established treatment plan.

b. Indicate “Yes” if a patient received all scheduled chemotherapy doses on time and completed the entire cycle of treatment.

c. Indicate “No” if a patient does not complete a chemotherapy regimen or misses scheduled doses.

d. Indicate “Unknown” if the record states that chemotherapy was received; however, no schedule information is available.

e. Indicate “N/A” if the patient did not receive chemotherapy.

CRF 5 – RESPONSE EVALUATIONNote: This form is completed multiple times.

A response evaluation time point should be based on a MRI/CT image. If one of the following four (4) criteria are met it is considered a response evaluation time point: Post Radiation, Reported Objective Response, Reported Progression, and/or Final Time Point. Multiple criteria may apply to a given time point. Select all that apply.

1. Date of response evaluation time point (mmm.dd.yyyy):a. Date should reflect the corresponding MRI/CT date. b. If MRI/CT is unavailable the corresponding clinic note may be used.

2. Post radiation therapy:

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a. Refers to the period of time immediately following the completion of a radiation therapy regimen.

b. Refer to the radiation therapy timeline and select the first documented image (MRI/CT) available following the completion of a radiation therapy.

c. If no image is immediately available a clinic note may be substituted.d. Indicate “N/A” if time point is not post-radiation. e. Indicate “Unknown” if radiation therapy timeline cannot be accurately assessed.

3. Response observed: a. Refers to any documented measurable improvement related to treatment.b. Examine both clinic notes and MRI/CT reports. c. Indicate “Clinical” if the report confirms the patient’s clinical status has improved

or signs/symptoms have improved. d. Indicate “Image” if the report confirms via MRI/CT the patient’s lesion has

improved or decreased in size. e. Indicate “Both” if the reports confirm the patient’s clinical signs/symptoms

improved and the patient’s lesion has improved or decreased in size.f. Indicate “N/A” if no measurable response is available.

4. Progression observed:a. Refers to any documented deterioration in clinical signs/symptoms or observed

spread/expansion of patient’s lesion via MRI/CT. b. Examine both clinic notes and MRI/CT reports. c. Indicate “Clinical” if the report confirms the patient’s clinical status has

deteriorated or signs/symptoms have worsened in severity. d. Indicate “Image” if the report confirms via MRI/CT the patient’s lesion has

worsened in severity, spread, or increased in size.e. Indicate “Both” if the reports confirm the patient’s clinical signs/symptoms have

worsened and the patient’s lesion has worsened in severity, spread, or increased in size.

f. Indicate “N/A” if no report of progression if available. 5. Final time point:

a. Refers to the last available documented contact with the patient prior to death. b. Use MRI/CT reportc. Indicate “Yes” if this time point is the last available documented contact with the

patient prior to death.d. Indicate “No” if this time point is not the last available documented contact with

the patient prior to death.e. Indicate “Unknown” if the patient’s status is unavailable.

– IMAGE EVALUATION –

6. Was a MRI/CT completed at response evaluation time point?

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a. Refers to MRI/CT that corresponds with the designated time point. b. Indicate “Yes” if a MRI/CT was performed and can be associated with the

designated time point. c. Indicate “No” if no reports confirm no MRI/CT was performed or if no image can

be associated with the designated time point. d. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 7. Type of image obtained at evaluation:

a. Refers to the type of image obtained at response evaluation time point; magnetic resonance imaging (MRI) or computerized tomography (CT scan).

b. Indicate “MRI” if a MRI was obtained at response evaluation time point. c. Indicate “CT” if a CT was obtained at response evaluation time point. d. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 8. Date of MRI/CT (mmm.dd.yyyy):

a. Refers to MRI/CT that corresponds with the designated time point. b. Should directly correspond to question #1 CRF5 if an image was available. c. Indicate “N/A” if no image record is associated with the time point.

9. If MRI/CT was not performed or date is unavailable:a. Indicate “Unknown” if record confirms an image was obtained at designated time

point; however, there is no date associated with the report.10. If MRI/CT was completed, was metastatic disease reported in the brain?

a. Refers to MRI/CT that corresponds with the designated time point. b. Review MRI/CT report and corresponding clinic notes if necessary. c. Indicate “Yes” only if the image report clearly states that metastatic disease was

observed in the brain. d. Indicate “No” if the image report states no metastatic disease was observed or if

a complete report makes no mention of metastatic disease. e. Indicate “N/A” if no image record is associated with the time point. f. Indicate “Unknown” if an image is associated with the time point; however, the

image report and/or results are unavailable. 11. If MRI/CT was completed, was metastatic disease reported in the spine?

a. Refers to spine MRI/CT that corresponds with the designated time point. b. Review spine MRI/CT report and corresponding clinic notes if necessary. c. Indicate “Yes” only if the image report clearly states that metastatic disease was

observed in the spine. d. Indicate “No” if the image report states no metastatic disease was observed or if

a complete report makes no mention of metastatic disease in the spine. e. Indicate “N/A” if no image record is associated with the time point. f. Indicate “Unknown” if an image is associated with the time point; however, the

image report and/or results are unavailable. 12. Was new or worsening of prior hydrocephalus present?

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a. Refers to the observed presence of new or worsening hydrocephalus at the designated time point.

b. Indicate “Yes” if the record confirms new or worsening hydrocephalus is observed at the designated time point.

c. Indicate “No” if the record confirms no hydrocephalus is observed, no mention of hydrocephalus is made, or if previously reported hydrocephalus remains stable.

d. Indicate “Unknown” if hydrocephalus is reported; however it cannot be determined when hydrocephalus was first observed.

e. Indicate “N/A” if no image record is associated with the time point.f. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 13. Did the MRI/CT report state evidence of relapse or progression of disease?

a. Refers to MRI/CT that corresponds with the designated time point. b. Review MRI/CT report and corresponding clinic notes if necessary. c. “Relapse” refers to the return of disease after a period of improvement.d. “Progression” refers to the worsening or spread of disease within the body. e. Indicate “Yes” only if the image report clearly states that relapse or progression

of disease was observed. f. Indicate “No” if the image report states no relapse or progression of disease was

observed or if a complete report makes no mention of relapse or progression. g. Indicate “N/A” if no image record is associated with the time point. h. Indicate “Unknown” if an image is associated with the time point; however, the

image report and/or results are unavailable. 14. If applicable, what degree of response was confirmed in the MRI/CT report?

a. Refers to MRI/CT that corresponds with the designated time point. b. Review MRI/CT report and corresponding clinic notes if necessary. c. Refers to any documented measurable improvement or decrease in lesion size

related to treatment observed via imaging. d. Minor Response (MR): "Minor response" roughly means a small amount of

shrinkage. Minor response is not really a standard term but is increasingly used. Roughly speaking, a minor response is more than 25% of total tumor volume but less than the 50%.

e. Partial response (PR): “Partial response refers to a decrease of 50% or more in the sum of total tumor volume.

f. Complete response (CR): “Complete response” refers to the disappearance of all target lesions in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

g. Indicate “Unspecified” if the report confirms a response; however, the degree of response cannot be determine or is unavailable.

h. Indicate “N/A” if no response was observed or reported. 15. Specify the type of tumor relapse or progression:

a. Refers to MRI/CT that corresponds with the designated time point. b. Review MRI/CT report and corresponding clinic notes if necessary.

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c. For the purposes of this question “Progressive disease” refers to any observable worsening, growth, and/or spread of disease while not receiving treatment.

d. “Refractory” refers to cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment or it may become resistant during treatment. Also called resistant cancer.

e. “Recurrent” refers to cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence.

f. “Second Primary” refers to a new primary cancer in a person with a history of cancer.

g. Indicate “N/A” if no relapse or progression of disease is observed or reported. 16. Specify the time from diagnosis to first progression (in months):

a. Refers to the period of time from initial diagnosis to first documented progression. b. Identify the date of diagnosis (refer to question #1 CRF3) and the date of

documented first progression. Use an age calculator to determine length of time in months from diagnosis to progression (enter diagnosis date in for “Date of birth” and enter progression date in for “Age at this date”.

c. Span of time should be rounded up if necessary.i. http://www-users.med.cornell.edu/~spon/picu/calc/agecalc.htm

17. If progression has not been observed or the time from diagnosis to first progression is unavailable:

a. Indicate “N/A” if no progression of disease is observed or reported. b. Indicate “Unknown” if progression was confirmed during the time point; however,

exact dates are unavailable. 18. Specify tumor location:

a. Refers to the general site of the tumor within the brain and corresponding structures impacted.

b. May be found in the clinic notes, image reports, or pathology report if available.19. If progression has not been observed or tumor location is unavailable:

a. Indicate “N/A” if no relapse or progression of disease is observed or reported. b. If a significant number of reports are missing from a record so that patient history

may not be assessed select “Unknown”. 20. Was MR spectroscopy completed at response evaluation time point?

a. Indicate “Yes” if MRS report is on file or there is a report of a MRS procedure in the clinic notes during the designated time point.

b. Indicate “No” if no report exists that a MRS was collected during the designated time point.


21. Date of MR spectroscopy (mmm.dd.yyyy):a. Found in MRS report or clinic note.

22. If MR spectroscopy was not performed or date is unavailable:

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http://www-users.med.cornell.edu/~spon/picu/calc/agecalc.htm



a. Indicate “Unknown” if report confirms a MRS was completed at designated time point; however, there is no date associated with the report.

b. Indicate “N/A” if MRS was not performed. 23. Was a PET completed at response evaluation time point?

a. Indicate “Yes” if PET report is on file or there is a report of a PET procedure in the clinic notes at the designated time point.

b. Indicate “No” if no record exists that a PET was collected during the designated time point.


24. Date of PET (mmm.dd.yyyy):a. Found in PET report or clinic note.

25. If PET was not performed or date is unavailable: a. Indicate “Unknown” if report confirms a PET was completed at designated time

point; however, there is no date associated with the report. b. Indicate “N/A” if PET was not performed.

26. If PET was completed, specify type:a. Found in PET report or clinic note.b. Type of PET refers to the type of tracer used during the scan.

Fluorodeoxyglucose (FDG) and methionine (MET) are the most widely used tracers for oncological PET studies.

c. Indicate “FDG” if the reports confirm a PET was obtained using FDG. Sometimes referred to as a FDG-PET scan.

d. Indicate “Methionine” if the reports confirm a PET was obtained using methionine or MET.

e. Indicate “N/A” if a PET was not obtained. f. Indicate “Unknown” if the reports confirm a PET was performed; however the

type of tracer used is unavailable.

– CLINICAL EVALUATION –

27. Did the patient have a clinical response evaluation?a. Refers to a physical evaluation of the patient to assess symptoms, response to

treatment, or reactions to therapy. b. Examine clinic notes to identify any physical evaluation associated with the

designated time point or associated imaging. c. Indicate “Yes” if the patient’s physical status was evaluated at the designated

time point or an evaluation was performed in conjunction with time point imaging.d. Indicate “No” if the report confirms the patient’s physical status was not evaluated

at the designated time point or no report is available in a complete record. e. If a significant number of reports are missing from a record so that patient history


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28. Date of clinical response evaluation (mmm.dd.yyyy):a. Refers to clinical evaluation that corresponds with the designated time point or

associated imaging. b. Clinical evaluation and associated imaging may be completed on different dates.

29. If clinical response evaluation was not performed or date is unavailable: a. Indicate “N/A” if no image record is associated with the time point. b. Indicate “Unknown” if the report confirms an evaluation was completed at the

designated time point; however, the exact date cannot be accurately assessed. 30. Weight in kilograms at time of evaluation:

a. Examine clinic note for patient weight at time of physical evaluation. c. A weight converter may be used if necessary:

i. http://www-users.med.cornell.edu/~spon/picu/calc/convert.htm 31. If weight at time of evaluation is unavailable: 32. Clinical presentation of neurological symptoms at time of evaluation:

a. Refers to the patient’s physical status reported at designated time point. b. “Progression” refers to the presence of new observed symptoms, worsening of

prior symptoms, and/or general deterioration of physical and neurological status.c. “Response” refers to an improvement in observed symptoms related to

treatment. d. “Stable” refers to observed symptoms that are neither decreasing nor increasing

in extent or severity.e. “Complete Resolution” refers the disappearance of all associated symptoms. f. Indicate “N/A” if the patient did not receive a physical evaluation at the

designated time point. g. Indicate “Unknown” if the report confirms the patient did receive a physical

evaluation; however, the results are unknown or unavailable. 33. Has the patient’s treatment changed since last time point?

a. Refers to any changes in radiation, chemotherapy, or surgical status. b. Includes any new or additional treatments that have not been documented. c. Does not include patient’s status changing to “off-treatment” or “off-study”. d. Should only include any changes in treatment in between documented time

points. Treatments should not be re-reported or carried over to later time points once documented.

e. Includes any treatment between diagnosis and first documented time point, as well as final documented time point and death.

f. Examine clinic and treatment notes for necessary information. g. Indicate “Yes” if the report confirms there have been changes in the patient’s

treatment regimen, including; enrollment in any new clinical trial or therapeutic protocol or any new course of radiation, chemotherapy, or surgical procedure not associated with a clinical trial or therapeutic protocol.

h. Indicate “No” if the report confirms there have been no changes in the patient’s treatment regimen or the patient has not received any treatment.

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i. If a significant number of reports are missing from a record so that patient history may not be assessed select “Unknown”.

34. Specify any/all changes in treatment since last time point:a. Refers to any changes in radiation, chemotherapy, or surgical status. b. Includes any new or additional treatments that have not been documented.c. Should only include any changes in treatment in between documented time

points. Treatments should not be re-reported or carried over to later time points once documented.

d. Includes any treatment between diagnosis and first documented time point, as well as final documented time point and death.

e. Does not include patient’s status changing to “off-treatment” or “off-study”. f. Examine clinic and treatment notes for necessary information. g. Multiple types of treatment may be applicable. Select all that apply. h. Indicate “Surgery” if the report confirms the patient underwent brain specific

surgery (e.g. resection, biopsy, or shunt placement). i. Indicate “Radiation” if the report confirms the patient was treated with a new

course of radiation therapy. j. Indicate “Chemotherapy” if the report confirms the patient was treated with a new

course of chemotherapy. k. Indicate “N/A” if the report confirms there have been no changes in the patient’s

treatment regimen or the patient has not received any treatment. 35. If change in chemotherapy specify regimen/protocol:

a. Indicate any changes in chemotherapy drug or associated protocol. b. Does not include patient’s status changing to “off-treatment” or “off-study”. c. If available, specify chemotherapy regimen and/or trial/protocol name.

36. If there is no change in chemotherapy or new/updated regimen/protocol is unavailable:

a. Indicate “N/A” if the report confirms there have been no changes in the patient’s chemotherapy treatment or the patient has not received chemotherapy.

b. Indicate “Unknown” if the record confirms there has been in a change in the patient’s chemotherapy regimen; however, the specific change cannot be determined.

37. Is the patient alive at time of evaluation?a. Refers to the patient’s status during evaluation at designated time point. b. Indicate “Yes” if the record confirms the patient is alive at time of physical

evaluation associate with designated time point.c. Indicate “No” if the record confirms the patient is deceased at time of physical

evaluation associated with designated time point. d. Indicate “Unknown” if the patient’s status cannot be determined at time of

physical evaluation and designated time point. 38. If deceased, indicate the date of death (mmm.dd.yyyy):

a. Refers to the confirmed date of death. b. May be found in final clinic note, death note, or autopsy report.

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39. If patient is alive at time of evaluation or date of death is unavailable: a. Indicate “N/A” if the report confirms the patient is not deceased at designated

time point.b. Indicate “Unknown” if the patient is deceased at the designated time point;

however, the exact date of death cannot be accurately determined.

CRF 7 – PATHOLOGY REVIEW Only complete for patients with tissue.

Note: Q.10-29 to be completed only by the Registry pathologist.

All fields must be completed as accurately and completely as possible. Unless unavoidable, do not leave empty or blank fields. Any unanswered fields may be subject to query and additional documentation.

1. Date tissue obtained (mmm.dd.yyyy): a. Indicate date tissue was obtained.

2. Type of tissue collected:a. Indicate type of tissue collected.

3. Tissue obtained from:a. Indicate method used to obtain tissue.

4. Tissue deposited in the repositorya. Indicate if the tissue has been shipped to the DIPG Registryb. Indicate “N/A” if tissue is unable to be sent.

5. Were genomics performed on the obtained tissue?a. Indicate if the tissue has been sent for WES or WGS sequencing

6. Were clinical genomics performed?a. Indicate if a limited clinical sequencing panel was performed

7. If yes, is the report available?a. Indicate if a report is available and please send a copy.

8. Histology:a. Indicate tumor type grade based on the World Health Organization 2016

classification. 9. If other, indicate in comments:

a. Provide comments if other is marked

CRF 8 – BIOINFORMATICS ANNOTATION Only complete for patients with tissue.

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1. Are the patient’s genomics deposited in the repository?a. Indicate if the data has been sent to the DIPG Registryb. Indicate “N/A” f genomic information is unavailable from tissue specimens or has

not been performed 2. Mark all genomic studies performed:

a. Specify which studies were performed:b. Options are WES, WGS, RNA-Seq, Methylation Arrayc. Indicate “NA” if patient history cannot be assessed.

3. Targeted Genomics performed:a. Specify the results of all genomic studies performed on the obtained tissue. Mark

if mutation is present or absent for the following; H3F3A, HISTIH3B, PDGFRA (mutation and/or amp), TP53, PPMID, ACVR1, PIK3CA, NMYC (amp), MYC-PVT1 (amp), ATRX

b. Indicate “NA” if the genomics were not performed.4. Is the patient’s genomics or biology data published?

a. Indicate “Yes” if patient’s genomics/biology have been published. b. Indicate “No” if patient’s genomics/biology have not been published. c. Indicate “Unknown” if patient history cannot be assessed.

5. If yes, specify what publication(s):a. Specify publication(s) and journal name.

6. If publication information is unavailable: a. Indicate “NA” if patient genomics are not publishedb. Indicate “Unknown” if journal is not known.

7. Publication date if applicable (mmm.dd.yyyy):a. Include date published.

8. If publication date is unavailable:a. Indicate “NA” if patient genomics are not publishedb. Indicate “Unknown” if date is not known.

9. Additional comments:a. Include any additional information that may help avoid duplicate studies on tissue

that has already been published.

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