BCB-Sarcomes: National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group

Sponsor

Institut Bergonié (Other)

Overall Status

Recruiting

CT.gov ID

NCT03978039

Collaborator

French Sarcoma Group (Other)

20,000

Enrollment

Locations

251

Anticipated Duration (Months)

6666.7

Patients Per Site

26.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The BCB SARCOMES database is a clinical and biological national database dedicated to sarcoma that contains 3 main databases with specific aims: the first is the pathology database (French expert network dedicated to the management of bone sarcomas [RESOS] / French expert network dedicated to the pathology of sarcomas [RREPS]), dedicated to systematic review of mesenchymal tumor diagnostics nationwide; the second is clinical (RESOS / French expert clinical network for sarcomas [NETSARC]), collecting multidisciplinary tumor boards (MDTB) data of patients nationwide, and the third (CONTICABASE / BONE / GIST) is dedicated to collecting patients longitudinal/follow up data, with a focus on treatments of every events, and a catalogue of associated samples.

Primary objectives of BCB-SARCOMES are the following: description of the patterns of care and treatment outcomes, assessment of the prognostic factors of patients' outcomes.

With the financial support of the French National Cancer Institute [Institut National du cancer [INCa]).

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: Chemotherapy Drug: Immunotherapeutic Agent Drug: target treatment Procedure: Surgery Radiation: Radiotherapy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas

Actual Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

Time to next treatment (TNT) [2 years]
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Time to next treatment (TNT) [5 years]
Time from the systemic treatment onset to the next treatment or death due to any cause, whichever comes first. When neither death nor new systemic therapy is observed, TNT is censored at the date of last patient contact.
Overall survival (OS) [2 years]
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.
Overall survival (OS) [5 years]
Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

sarcoma

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	Country
1	Institut Bergonié, Comprehensive Cancer Center	Bordeaux	France
2	Centre Léon Bérard	Lyon	France
3	Institut Gustave Roussy, Comprehensive Cancer Center	Villejuif	France