NETSARC - NATIONAL PROSPECTIVE COHORT ON SARCOMAS/GIST/DESMOID AND CONNECTIVE TISSUE TUMOURS
Head :
Blay Jean-Yves, INSERM U570
Ray-Coquard Isabelle, EAM Santé Individu Société 4129 Universités Lyon 1/ Lyon 2 / Lyon 3
Ray-Coquard Isabelle, EAM Santé Individu Société 4129 Universités Lyon 1/ Lyon 2 / Lyon 3
Last update : 02/05/2016 | Version : 3 | ID : 8158
| General | |
| Identification | |
| Detailed name | NATIONAL PROSPECTIVE COHORT ON SARCOMAS/GIST/DESMOID AND CONNECTIVE TISSUE TUMOURS |
| Sign or acronym | NETSARC |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL DR-2013-383, CCTIRS 16/09/2010 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Genetic Geography Iatrogenic |
| Keywords | Sarcoma, rare cancers, network, clinical, biological samples, ISKS project, genetic, treatment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Blay |
| Surname | Jean-Yves |
| Address | 28, rue Laennec 69373 LYON CEDEX 08 |
| Phone | +33 (0)4 78 78 51 26 |
| jean-yves.blay@lyon.unicancer.fr | |
| Unit | INSERM U570 |
| Organization | Centre Léon Bérard |
| Name of the director | Ray-Coquard |
| Surname | Isabelle |
| Address | 28, rue Laennec 69373 LYON CEDEX 08 |
| Phone | +33 (0)4 78 78 28 29 |
| isabelle.ray-coquard@lyon.unicancer.fr | |
| Unit | EAM Santé Individu Société 4129 Universités Lyon 1/ Lyon 2 / Lyon 3 |
| Organization | Centre Léon Bérard |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Pour le projet ISKS spécifique : - INFO SARCOMES (association de patients)- LIDDY SHRIVER (association de patients)Recherche de financements additionnels |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre Léon Bérard |
| Organisation status |
Private |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | - patients with sarcoma or connective tissue tumours (all ages and histologies) discussed in multidisciplinary meetings (RCP) in regional centres of expertise specialising in the treatment of sarcomas |
| Database objective | |
| Main objective | The objectives of this cohort are: real-time integration of patients into a database- to generate real-time national and regional descriptive data for all patients with sarcoma - to provide national indicators of patient care and equal access to care and innovative treatments - to improve knowledge of rare tumours - to investigate the link between sarcomas and genetics. |
| Inclusion criteria | - patients with sarcoma or connective tissue tumours (all ages and histologies) discussed in multidisciplinary meetings (RCP) in regional centres of expertise specialising in the treatment of sarcomas |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) 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 |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | The national NETSARC clinical network is composed of 28 regional centres of expertise specialising in sarcoma treatment and research. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 17 346:- 11 646 sarcomes/GIST/desmoide.- 5 700 tumeurs conjonctives à malignité intermédiaire ou bénigne. |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | > Tumor (shared): location, size, depth of invasion > Tumor sample description (from RRePS): case origin, sample type, sample date, diagnosis establish by anatomic pathology structure, by the national reference center, by the coordination site, tumor immunohistochemistry, tumor molecular biology, tumor FISH exam > Main steps of patient management (from NetSarc): tumor type, diagnosis, date of the first diagnosis, stages of cancer, imaging data before resection, biopsy, place and quality of surgery > Multidisciplinary consensus meeting (from NetSarc): date, expert center, timing, decisions > Inclusion in clinical trials (from NetSarc): date, name of clinical trial > Relapse, date of death, date of last follow-up (from NetSarc) |
| Declarative data (detail) |
Paper self-questionnaire |
| Biological data (detail) | DNA |
| Administrative data (detail) | > Demographic : date of birth, initial, gender, current geographic residence, antecedents |
| Presence of a biobank |
Yes |
| Contents of biobank |
DNA |
| Details of biobank content | DNA |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation |
| Procedures | |
| Data collection method | Standardised reports from regional centres specialising in the treatment of sarcomas included in the network. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Frequent return to medical record while patient is undergoing treatment and follow-up in the centre. Return every 2 years during follow-up outside centres via mail addressed to correspondents. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | NetSarc.pdf |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Shared database is accessible online and developed by two network I.T. professionals. Data is hosted by a professional hosting provider. Users can connect with a unique password. Different rights are allocated per profile (clinician, clinical research associate, quality manager, administrator ...). Website terms of use must be previously signed. Non-identifiable patient data (HASH system is being put in place). A scientific committee consisting of representatives clinicians and pathologists centres to large volume of patients in the network is responsible for controlling, analysing and authorising requests for studies from the shared data base. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
