Barcelona meeting

23 + 24 February 2012

Who are we? What are we? Why are we?

Under what conditions?

• SIOP-E DIPG network (SIOPE-DIPG) established in 2011 by members from the UK, France, Germany, Italy, Spain, Belgium and the Netherlands

• First meeting in Amsterdam, 14-15th January 2011

SIOP-E DIPG Network

Introduction to the network

Aims of SIOPE-DIPG

– Bring together clinicians and researchers with an interest in DIPG

– Initiate a European DIPG registry

– Initiate a European DIPG website

– Initiate European retrospective studies

Introduction to the network

Aims of SIOPE-DIPG

– Initiate collaborative clinical trials with uniform

in-/exclusion criteria, response criteria, endpoints

– Initiate collaborative biological studies

– Serve as a resource for those interested in DIPG

– Disseminate information about DIPG – professionals and patients / parents

Introduction to the network

Country National Coordinator

Austria Irene Slavc

Belgium Stefaan Van Gool

Czech Repulic David Sumerauer

France Pierre Leblond

GPOH Christof Kramm

Ireland Jane Pears

Italy Veronica Biassoni

Netherlands Dannis van Vuurden

NOPHO Sanna-Maria Kivivuori

Poland Marta Perek-Polnik

Portugal Maria João Gil-da-Costa

Spain Ofelia Cruz Martinez

UK Simon Bailey

Countries TBA

Bulgaria Hungary

Estonia Latvia, Lithuania

Greece Albania

Belarus Serbia, Bosnia, Croatia

Greece Rumania, Russia

Estimated European DIPG Incidence

Where do we go frome here?

Project 1: Registry of European long term DIPG survivors

• Typical DIPG patients based on clinical and radiological data • Survival > 24 months • Anonymized data collection (web-based CRFs)

– Demographics – Symptoms & signs at diagnosis and their duration – MRI features at diagnosis and during disease (Digital Review) – Pathology review (if available) – Treatment regimen – Clinical and radiological) response to treatment

Introduction to the network

Kaplan-Meier curve of survival of children diagnosed with a brainstem glioma in the Netherlands in the past 20 years. At 24 months after diagnosis, a survival of 81% (25/31), 45% (10/22) and 9% (8/88) was observed for non pontine brainstem, focal pontine and diffuse pontine glioma respectively.

Project 1: Registry of European long term DIPG survivors Dutch Childhood Oncology Group (DCOG/SKION)

provides DCOG Digital Review web application Web application linked to coded clinical data from a

ProMISe database managed by MSBI.

DCOG Digital Review web application Data safety / protection measures

1. Sessions a. An authorized user can login on one computer only

at a time (IP-address filtering) b. Automatically log-off after 30 minutes of in-activity

2. Information encryption a. Input data is being encrypted (SSL- certificate) b. Passwords are stored encrypted

DCOG Digital Review web application Data safety / protection measures

3. Different levels of authorization a. The rights of the user and level of authorization is

determined per type of review b. The authorization level of the user determines

access to functionalities and visibility of patient data and write/change abilities.

DCOG Digital Review web application Data safety / protection measures

4. Digital signature By signing a form with password/signature the

reliability of the data is verified. 5. The clinical patient data is stored in a ProMISe

database which is NEN7511 certified.

Imagys Digital Imaging Platform - Real-time image visibility and interaction

via web-portal

- Image repository and document management system - Secure, real-time view of imaging data from

anywhere in the world

- Formats: CT, MRI, X-rays, Ultra-sound, PET/CT, SPECT/CT, NM and medical photography, eCRFs and supporting documentation

Budget

European DIPG Registry, facilitated by DCOG

Startup Digital CRF development Database development Web application development Web application validation Web application startup Total (once) 11960 EUR

Budget

European DIPG Registry, facilitated by DCOG

Maintenance Data validation (110 pt/year) Queries Database maintenance Web application maintenance Total (per year) 7475 EUR

Budget Imagys platform / database

for banking and digital review of imaging (radiology / nuclear medicine)

License for reviewing system SOS.Imagys.com

Total (per year): 7,500 EUR

Budget First year: 26935 EUR Following years: 14975 EUR per year

Supports the Registry idea, both in USA-Canada-

Australia and Europe Willing to fund startup: 24756 USD (18584 EUR)

+

Issues:

- Setting up a contract / partner agreement - How to acknowledge all parties (authorship etc) - Radiology review panel - Pathology review panel - Data protection (officer?) - European DIPG website (patients/professionals) - Financing / funding

SIOPE DIPG Network Registry Partnership Agreement

• Who are parties in the SIOPE DIPG network? The Parties are academic hospitals and/or research institutes

based in Europe and have considerable knowledge, expertise and experience in research in the field of pediatric neuro-oncology and treat children with diffuse intrinsic pontine glioma (DIPG) and/or perform preclinical research in DIPG

SIOPE DIPG Network Registry Partnership Agreement

• What are the aims of the parties in this partnership? The parties have the aim to…

– Bring together clinicians and researchers with an interest in DIPG

– Be a platform to initiate European retrospective studies in DIPG

– Initiate and support an anonimized European database with clinical data, imaging and pathology in DIPG

– Initiate and conduct collaborative clinical studies with uniform in- and exclusion criteria, response criteria, endpoints

SIOPE DIPG Network Registry Partnership Agreement

• The parties have the aim to… – Initiate and conduct collaborative biological studies – Set up a structure to serve as a resource for those interested in

DIPG – Disseminate information about DIPG, both to professionals and

patients and parents – Parties wish to specify the terms and conditions of their

collaboration further in this Agreement

SIOPE DIPG Network Registry Partnership Agreement

We need to establish: – Supervisory Board – Management Team – Secretariat – Program Leader(s) per project

SIOPE DIPG Network Registry Partnership Agreement

We need to describe clearly: – The DIPG registry / database – Imaging reviewing platform – Budget and Financing of the SIOPE DIPG network – Budget and Financing of the registry and projects from the

registry – Intellectual Property and Publication – Data protection – Authorship

How to handle collaborations with 3rd parties outside the SIOPE DIPG Network?