ITMO public health
Last update : 10/22/2018 | Version : 2 | ID : 73088
| General | |
| Identification | |
| Detailed name | French glioblastoma biobank |
| Sign or acronym | BCB Glioblastomes |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL02/2013 (1476342v2) ; CPP 23/12/2011-26/02/2013 |
| General Aspects | |
| Medical area |
Anatomy - Cytology Biology Cancer research Neurology Radiology and medical imaging |
| Pathology (details) | Glioblastoma |
| Health determinants |
Genetic Geography Occupation |
| Keywords | Glioblastoma, malignant tumour, tumour, clinical and biological database, central nervous system, bioresource, biobank |
| Scientific investigator(s) (Contact) | |
| Name of the director | Menei |
| Surname | Philippe |
| Address | Service de Neurochirurgie - CHU Angers - 4 rue Larrey - 49000 Angers |
| Phone | +33 2 41 35 48 22 |
| phmenei@chu-angers.fr | |
| Unit | CRCINA Inserm U1232 team 17 |
| Organization | CHU Angers |
| Name of the director | Bauchet |
| Surname | Luc |
| Address | Servide de Neurochirurgie - CHRU Gui de Chauliac - 80 av Augustin Fliche - 34090 Montpellier |
| l-bauchet@chu-montpellier.fr | |
| Organization | CHU Montpellier |
| Name of the director | Figarella-Branger |
| Surname | Dominique |
| Address | AP-HM Timone - Service d'anatomie et cytologie pathologiques et de Neuropathologie - 264 rue Saint-Pierre - 13385 Marseille Cedex 05 |
| DominiqueFrance.FIGARELLA@ap-hm.fr | |
| Organization | Hôpital Timone Marseille |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | French glioblastoma biobank |
| Funding | |
| Funding status |
Public |
| Details | INCA, IBISA |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU Angers |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Labelling and database evaluation | NF96-900, ISO9001 |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Patients with first surgery for glioblastoma, who have given their consent. |
| Database objective | |
| Main objective | The principal purpose of this project is to, over three years, build a national, representative and well-annotated clinical and biological database (CBD) of at least 1,200 glioblastomas. |
| Inclusion criteria | Patients with first surgery for glioblastoma who have given their consent. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| G93 - Other disorders of brain | |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 29 sites in France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1099 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | history, surgery, anatomopathology, mri before surgery, follow up every 6 month and cancer treatments |
| Paraclinical data (detail) | MRI before surgery (images and data) |
| Biological data (detail) | Tumoural and peri-tumoral tissue (paraffin block, cryofragment), Blood (plasma, serum, total blood, buffy coat), hair, initial and recidive surgery, before and after surgery |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Tissues Cell lines DNA Others |
| Details of biobank content | Tissue fragment, blood, hair |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | anonymous ennov clinical database for clinical data (Clinsight) and biological resources stored in certified Biological Resources Centers |
| Classifications used | ADICAP, CIM10, OMS |
| Quality procedure(s) used | data-management team certified ISO9001, resources stored in certified Biological resources centers NF96-900 |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | Follow-up every 6 month until death |
| Followed pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | https://www.ncbi.nlm.nih.gov/pubmed/24739367 |
| Link to the document | https://www.ncbi.nlm.nih.gov/pubmed/29454008 |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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