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

Sarcoma Clinical Trial

— BCB-Sarcomes  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978039
• Other study ID #: IB2012-BCB-SARCOMES
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2030

Study information

• Verified date: July 2023
• Source: Institut Bergonié
• Contact: Maud Toulmonde, MD
• Phone: 0556333333
• Email: m.toulmonde[@]bordeaux.unicancer.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2030
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• sarcoma

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Sarcoma

Intervention

Drug:
• Chemotherapy
treatment as per standard of care
• Immunotherapeutic Agent
treatment as per standard of care
• target treatment
treatment as per standard of care

Procedure:
• Surgery
treatment as per standard of care

Radiation:
• Radiotherapy
treatment as per standard of care

Locations

Country	Name	City	State
France	Institut Bergonié, Comprehensive Cancer Center	Bordeaux
France	Centre Léon Bérard	Lyon
France	Institut Gustave Roussy, Comprehensive Cancer Center	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	French Sarcoma Group

Country where clinical trial is conducted

France, 

References & Publications (3)

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, M — View 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 pati — View 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; Fren — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to next treatment (TNT)	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.	2 years
Primary	Time to next treatment (TNT)	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.	5 years
Primary	Overall survival (OS)	Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.	2 years
Primary	Overall survival (OS)	Interval between diagnosis and the time of death. When death is not observed, OS is censored at the date of last patient contact.	5 years

External Links

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