Division of Surgical Research – Research, Educational and Institutional Projects Christine L....

Division of Surgical Research – Research, Educational and Institutional Projects

Christine L. Carter, Ph.D., M.P.H.

Director of Surgical ResearchResearch Professor of Surgery

Tel: 202 741 3202Cell: 202 468 5073

Research Activities/InitiativesResearch Activities/Initiatives

Since February, 2004Since February, 2004

1. 9 Research Contracts Awarded/Pending:1. 9 Research Contracts Awarded/Pending:5 Contracts Funded5 Contracts Funded4 Pending IRB/Contract Approval 4 Pending IRB/Contract Approval

2.2. 2 Educational Initiatives2 Educational Initiatives Course “Conducting Research at GWU”Course “Conducting Research at GWU” Ethicon Endosurgery LabEthicon Endosurgery Lab

3.3. 2 Institutional Initiatives2 Institutional InitiativesCenter of Excellence in Bariatric SurgeryCenter of Excellence in Bariatric SurgeryObesity Center of Excellence – SMHS + SPHHS + Obesity Center of Excellence – SMHS + SPHHS + CNMCCNMC

..

Research Activities/InitiativesResearch Activities/Initiatives

Funded Currently (5)Funded Currently (5) 2 Device Studies (Pacer)2 Device Studies (Pacer) 2 Tissue Studies2 Tissue Studies 1 Questionnaire Validation Study1 Questionnaire Validation Study

Funded by Summer, 2005 (4 more)Funded by Summer, 2005 (4 more) 1 ACOSOG Clin Trial (Surg+Rad vs Surg)1 ACOSOG Clin Trial (Surg+Rad vs Surg) 1 NovoNordisk Clin Trial (Factor VII)1 NovoNordisk Clin Trial (Factor VII) 2 Drug Studies (Hemh.; Int-abd Inf)2 Drug Studies (Hemh.; Int-abd Inf)

Division of Surgical Research – Research ProjectsDivision of Surgical Research – Research Projects

Topic: Gastric Pacing - GastroparesisSponsor: Medtronic, IncStart/End Date: 4-04 – 4-06Total $ 84K (10 patients)Investigators: Nsien (PI), Brody, Carter, Drenon

TITLE: GASTRIC STIMULATION FOR VOMITING, NAUSEA AND RELATED SYMPTOMS ASSOCIATED WITH GASTROPARESIS USING ENTERRA ™ GASTRIC STIMULATION SYSTEM.

This is a device study for the treatment of chronic nausea and vomiting associated with gastroparesis when conventional drug therapies are not affective. Assessment of safety and effectiveness of implanted neurostimulator device used to control symptoms of gastroparesis.


Topic: Gastric Pacing - Obesity Sponsor: Transneuronix, Inc Start/End Date: 5-04-5-06 Total $ up to 400K Investigators: Brody(PI), Carter, Drenon

TITLE: SHAPE Screened Health Assessment & Pacer Evaluation

This is a device study. Therapy indicated for the treatment of obesity. Assessment of the safety and effectiveness of Transcend® Implantable Gastric Stimulation (IGS®) System to help obese patients loose weight and keep the lost weight off.

GastroparesisGastroparesis is a stomach disorder in which food moves is a stomach disorder in which food moves through the stomach more slowly than normal. In some through the stomach more slowly than normal. In some patients, this condition results in severe, chronic nausea and patients, this condition results in severe, chronic nausea and vomiting that cannot be adequately controlled by available vomiting that cannot be adequately controlled by available drugs. These patients have difficulty eating and may require drugs. These patients have difficulty eating and may require some form of tube feeding to ensure adequate nutrition.some form of tube feeding to ensure adequate nutrition.

Enterra Therapy uses mild electrical pulses to stimulate the Enterra Therapy uses mild electrical pulses to stimulate the stomach. This electrical stimulation helps control the stomach. This electrical stimulation helps control the symptoms associated with gastroparesis including nausea and symptoms associated with gastroparesis including nausea and vomiting.vomiting.

Enterra™ Therapy is indicated for the treatment of chronic Enterra™ Therapy is indicated for the treatment of chronic nausea and vomiting associated with gastroparesis when nausea and vomiting associated with gastroparesis when conventional drug therapies are not effective.conventional drug therapies are not effective.

Diabetes Mellitus/Gastroparesis Case Overview A 34-year-old diabetic man was referred with a 7-year history of severe gastroparesis. He had been unable to tolerate or had been unresponsive to conventional medical therapy for this condition. He was recently seen in his local hospital emergency room due to his inability to maintain minimal nutritional intake where a nasogastric tube was placed to decompress the abdomen. He had been hospitalized 10 times in the last year and vomiting up to 6 times a day. He had lost approximately 100 pounds over the last four years. The patient had a T-half emptying time of 280 minutes with no isotope leaving the stomach for two hours. Treatment The patient underwent abdominal ultrasound, gastric and small intestinal motility studies and a gastric emptying study to confirm gastroparesis. It was decided that he was an excellent candidate for insertion of the gastric pacemaker device.


Topic: Tissue Study in Young Colorectal Cancer Pts Sponsor: NIH/ACOSOG Start/End Date: 9-04 – 9-12 Total $ 2K per pt, n=10 Investigators: Orkin (PI), Katz (Co-PI), Schwartz (Pathologist),

Drenon

TITLE: ACOSOG Z0190.A PROSPECTIVE STUDY OF THE PROGNOSTIC SIGNIFICANCE OF MICROSATELLITE INSTABILITY(MSI) IN PATIENTS WITH EARLY AGE-OF-ONSET COLORECTAL CANCER.

Collection of diseased tissue from patients with a diagnosis of colorectal carcinoma, who are between the age of 18 and 50 years, and have or will undergo surgery for this condition. The analysis involves pathological review and MSI status of the tumor, and evaluation of prognostic significance of family history and MSI status.


Topic: Tissue Study – Breast Cancer Sponsor: Celera Genomics, Inc Start/End Date: 10-04 - 10-05 Total $2550 per pt, n=40 Investigators: Kelly (PI) Teal (Co-PI), Schwartz (Pathologist)

Drenon

This is a tissue study to obtain breast cancer specimens for proteomic analysis. The objective is to define molecular protein targets, present in cancer tissue and absent in the normal, adjacent tissue.

New diagnostic tests that provide information to physicians and patients that can be acted upon New therapies to intervene in disease development Therapies intended to address the needs of specific patient populations Improving the odds that a potential drug candidate will pass clinical testing and approval processes.

Collaboration: GWU/Celera Genomics

ProteomicsProteomics

Celera Genomics is using industrial-scale proteomics to evaluate cell surface proteins from normal and diseased tissues and cell lines. Findings are then used in an effort to identify candidate therapeutic targets for antibodies or small molecules. We do this by employing proprietary techniques to capture cell surface proteins and then by identifying and quantifying the proteins. Cell surface proteins are believed to represent the most promising targets for antibody therapeutics as near-term drug candidates.

Mass SpectrometryMass Spectrometry Mass spectrometry is the technique of choice for

identifying proteins of interest. In MS, the sample is first ionized, and the ions that are formed are measured by the mass spectrometer. This produces a mass spectrum, which enables scientists to determine the identity and quantity of the original protein by mass. Molecular weight and additional structural information may be obtained. It is a very sensitive technical capable of analysis at the parts per billion levels. For GWU studies, the intent is to determine the differential of proteins in tumor compared to normal tissue.

ABI Voyager-DE™STR

Celera has identified and validated differentially expressed proteins on the surface of cancer cells. Proteins that over-expressed on diseased cells relative to healthy cells may represent targets for therapeutic antibodies or small molecule drugs.

Pancreatic Cancer Identified over 110 differentially expressed cell surface proteins. Selected 25 proteins for validation as targets for antibodies and small molecules.

Non-small Cell Lung Cancer Processing tumor and normal tissue to identify differentially expressed proteins. Identified approximately 100 differentially expressed cell surface proteins.

Colon Cancer Processing tumor and normal tissue to identify differentially expressed proteins.

Breast Cancer Breast Cancer Processing tumor and normal tissue Processing tumor and normal tissue to identifyto identify differentially expressed proteins. differentially expressed proteins.

Pending Studies

Division of Surgical Research – Pending Research Division of Surgical Research – Pending Research ProjectsProjects

Topic: Retroperitoneal Sarcoma Trail Sponsor: NIH/ACOSOG Start/End Date: (pending approval) 3-05 – Total $ 2K per pt, n=5 Investigators: Hafner (PI), Schwartz, Harisiadis, Carter, Drenon

Title: A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients with Retroperitoneal Sarcoma.

This trial will evaluate whether preoperative radiotherapy of 45.0-50.4 Gy plus surgery improves the progression free survival

compared to surgery alone.


Topic: PPAR receptors in Obesity Sponsor: McCormick Grant, GWU Start/End Date: pending approval Total $ 15K Investigators: Carter (PI), Brody, Pinzone

TITLE: ANALYSIS OF GASTROINTESTINAL SPECIMENS.

Collection of tissue and blood from patients with a diagnosis of obesity and gastroparesis,(nerve damage to the stomach) who are undergoing surgery for these conditions. The analyses will involve gene and protein studies and is designed to develop a better understanding of the disease pathways.


Topic: Factor VII Trauma Study Sponsor: NovoNordisk Start/End Date: (pending approval) 6-05 – Total $ ? Investigators: Abell (PI), Silva (Co-PI), Carter, Drenon

Title: A Phase II Multi-center, Randomized Double-Blind Parallel Group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII in the Treatment of Refractory Bleeding in Severely Injured Trauma Subjects.


Topic: Ointment for Hemorrhoids Sponsor: Novartis Start/End Date: (pending approval) 6-05 – Total $ ? Investigators: Abell (PI), Silva (Co-PI), Carter, Drenon

Title: A Phase IIb Multi-center, Randomized Investigator-Blind Parallel Group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Iferanserin (ointment) in Patients with Mild to Moderate Symptomatic Hemorrhoids.


Topic: IV Antibiotic for Intra-abdominal Infections Sponsor: Wyeth Start/End Date: (pending approval) 6-05 – Total $ ? Investigators: Brody, Orkin, Katz, Carter, Drenon

Title: A Phase IV Multi-center, Randomized Investigator-Blind Parallel Group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Tigecycline in Patients with Intra-abdominal Infections.

Current Educational Initiatives

Division of Surgical Research –Educational Division of Surgical Research –Educational InitiativesInitiatives

Topic: Educational Grant for Laparascopic Tech. Sponsor: Ethicon Endo-Surgery, Inc. Start/End Date: 2-04 – 2-06 Total $ 641K Investigators: Giordano (PI), Carter, Li

This is an educational grant to support the Washington Institute for Surgical Endoscopy (WISE) laboratory for use by medical students, residents and other physicians interested in learning/improving assorted laparascopic surgical techniques. Inanimate and animate (pig) models are available.

Division of Surgical Research –Division of Surgical Research –Educational InitiativesEducational Initiatives

Title: Fundamentals of Conducting Research at GWU

Curriculum: 8-10 Modules, including– Proposal Development– Contract Review– IRB Review– Presentation to Conferences– Publication Process, etc

Course taught to Faculty, Medical Students, Surgical Residents

Current Institutional Initiatives

Feb 2005Feb 2005 Message Message

from Dr. from Dr. Skip Skip WilliamsWilliams

Goals for Goals for GWUMCGWUMC

““GWUMC is also looking atGWUMC is also looking atfunding new academic initiatives thatfunding new academic initiatives thatwill produce healthcare leaders forwill produce healthcare leaders forchallenging times. We have launched achallenging times. We have launched ajoint obesity initiative to examine thejoint obesity initiative to examine themedical and public health implicationsmedical and public health implicationsof what is now an epidemic ofof what is now an epidemic ofoverweight Americans. This initiativeoverweight Americans. This initiativewill join SMHS and SPHHS along withwill join SMHS and SPHHS along withour clinical partners at the GW Hos-our clinical partners at the GW Hos-pital and Medical Faculty Associates inpital and Medical Faculty Associates inexamining the problem and looking forexamining the problem and looking foracademic, research and clinical careacademic, research and clinical caresolutions. We intend to do this with oursolutions. We intend to do this with ouroutside partners so that this initiative isoutside partners so that this initiative isnot done in a vacuum.”not done in a vacuum.”

Provost Perspective:“Investing Resources and Energy in Goals that Move GWUMC Forward”

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