Clinical trial NCT03978039: National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Keywords: patterns of care
access to care
survival
experts' network
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
Collaborators: name: French Sarcoma Group
First posted: 2019-06-06
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sarcoma patients

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 \[INCa\]).


Eligibility criteria: Inclusion Criteria:

* sarcoma

Exclusion Criteria:

-

Primary outcomes:
measure: Time to next treatment (TNT)
timeFrame: 2 years
measure: Time to next treatment (TNT)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié, Comprehensive Cancer Center
city: Lyon
country: France
facility: Centre Léon Bérard
city: Villejuif
country: France
facility: Institut Gustave Roussy, Comprehensive Cancer Center
Study officials:
affiliation: Institut Bergonié, Bordeaux, France
name: Maud Toulmonde, MD
role: STUDY_CHAIR
affiliation: Institut Gustave Roussy, Villejuif, France
name: Axel Le Cesne, MD/PhD
role: STUDY_CHAIR
affiliation: Centre Léon Bérard, Lyon, France
name: Jean-Yves Blay, MD/PhD
role: STUDY_CHAIR
References:
citation: Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7.
citation: Toulmonde M, Bonvalot S, Meeus P, Stoeckle E, Riou O, Isambert N, Bompas E, Jafari M, Delcambre-Lair C, Saada E, Le Cesne A, Le Pechoux C, Blay JY, Piperno-Neumann S, Chevreau C, Bay JO, Brouste V, Terrier P, Ranchere-Vince D, Neuville A, Italiano A; French Sarcoma Group. Retroperitoneal sarcomas: patterns of care at diagnosis, prognostic factors and focus on main histological subtypes: a multicenter analysis of the French Sarcoma Group. Ann Oncol. 2014 Mar;25(3):735-742. doi: 10.1093/annonc/mdt577.
citation: Blay JY, Soibinet P, Penel N, Bompas E, Duffaud F, Stoeckle E, Mir O, Adam J, Chevreau C, Bonvalot S, Rios M, Kerbrat P, Cupissol D, Anract P, Gouin F, Kurtz JE, Lebbe C, Isambert N, Bertucci F, Toumonde M, Thyss A, Piperno-Neumann S, Dubray-Longeras P, Meeus P, Ducimetiere F, Giraud A, Coindre JM, Ray-Coquard I, Italiano A, Le Cesne A. Improved survival using specialized multidisciplinary board in sarcoma patients. Ann Oncol. 2017 Nov 1;28(11):2852-2859. doi: 10.1093/annonc/mdx484.