barcelona meeting 23 + 24 february 2012 · •siop-e dipg network (siope-dipg) established in 2011...
TRANSCRIPT
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?