ITMO public health
Last update : 07/19/2016 | Version : 1 | ID : 73335
| General | |
| Identification | |
| Detailed name | Epidemiology and treatment patterns in Soft Tissue Sarcoma (STS): a retrospective analysis on French expert centers databases |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL: 910390 |
| General Aspects | |
| Medical area |
Cancer research |
| Pathology (details) | Soft Tissue Sarcoma (STS) |
| Health determinants |
Healthcare system and access to health care services |
| Keywords | Soft Tissue Sarcoma (STS) |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pr BLAY |
| Surname | Jean-Yves |
| Address | LYON |
| Name of the director | Dr BUI NGUYEN |
| Surname | Binh |
| Address | BORDEAUX |
| Name of the director | Dr LE CESNE |
| Surname | Axel |
| Address | PARIS |
| Name of the director | Pr COINDRE |
| Surname | Jean- Michel |
| Address | BORDEAUX |
| Name of the director | Dr DUCIMETIERE |
| Surname | Françoise |
| Address | LYON |
| Name of the director | Pr MATHOULIN-PELISSIER |
| Surname | Simone |
| Address | BORDEAUX |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Partenariat public-privé : French Sarcoma Group (GFS) - MERCK |
| Funding | |
| Funding status |
Private |
| Details | Merck |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | French Sarcoma Group (GFS) |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Labelling and database evaluation | Scientific comittee |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| 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. | Retrospective databases analysis (RRePS, NetSarc, and Conticabase) by the French Sarcoma Group (GFS) |
| Database objective | |
| Main objective |
To describe the treatment patterns of advanced (unresectable locally advanced or metastatic) STS (including viscus sarcoma) patients in France.
Secondary objectives: - To describe STS (including viscus sarcoma) patients characteristics (sociodemographic data, type of sarcoma, histological subtype, tumor location, stage of the disease etc). - To assess the STS (including viscus sarcoma) incidence in France - To describe STS diagnosis (anatomopathology double review) and treatment history - To describe the duration of the different treatments of STS disease |
| Inclusion criteria | Patients with a diagnosis of STS, aged > 18 years-old, registered in the Conticabase/NetSarc/RRePS databases between January, 1st 2012 and December, 31st 2013 by a French expert center participating in the study between January, 1st 2012 and December, 31st 2013. |
| 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 |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/01/2012 |
| Date of last collection (YYYY or MM/YYYY) | 31/12/2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | Conticabase: N = 1099 / NetSarc: N= 4551 / RRePS: N=6812 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Sociodemographic characteristics of patients; Sarcoma epidemiology (type of sarcoma) ; STS epidemiology (histological subtype, tumor location, tumor depth, grade, stage at diagnosis, stage); Diagnosis (anatomopathology double review by an expert center, initial diagnosis, confirmatory diagnosis; Unresecable locally advanced or metastatic STS (1st line systemic treatment, 1st line CT and drug type, diagnosis date of unresecable locally advanced/metastatic stage, initiation date of the 1st line CT, date of progression after 1st line treatment, 2nd, 3rd and 4th line CT and drug type) |
| Presence of a biobank |
No |
| Procedures | |
| Data collection method | Extraction, treatment and analysis of the RRePS, NetSarc and Conticabase databases by the French Sarcoma Group (GFS) |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | 1697 poster sarcome colloque pharma epi 9juin15 ok.pdf |
| Description | Colloque PEP, juin 2015 |
| Link to the document | 1772 poster sarcome VF.pdf |
| Description | ISPOR, novembre 2015 |
| Link to the document | PEP2015_12_BCBSarcome_Coindre.pdf |
| Description | Communication orale, colloque PEP, juin 2015 |
| Access | |
| Presence of document that lists variables and coding procedures |
No |
| Terms of data access (charter for data provision, format of data, availability delay) |
Methods of access are currently being defined
Contact: juliette.longin@merckgroup.com |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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