- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03978039
National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group (BCB-Sarcomes)
The "BCB-sarcomes" Database: the Database of the French Sarcoma Group Dedicated to the Collection of Clinical and Biological Data for All Sarcomas
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]).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maud Toulmonde, MD
- Phone Number: 0556333333
- Email: m.toulmonde@bordeaux.unicancer.fr
Study Contact Backup
- Name: Simone Mathoulin-Pélissier, MD/PhD
- Phone Number: 05563333
- Email: s.mathoulin@bordeaux.unicancer.fr
Study Locations
-
-
-
Bordeaux, France
- Recruiting
- Institut Bergonié, Comprehensive Cancer Center
-
Contact:
- Maud Toulmonde, MD
-
Contact:
- Antoine Italiano, MD/PhD
-
Lyon, France
- Recruiting
- Centre Leon Berard
-
Contact:
- Jean-Yves Blay, MD/PhD
-
Villejuif, France
- Recruiting
- Institut Gustave Roussy, Comprehensive Cancer Center
-
Contact:
- Axel Le Cesne, MD/PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria :
- Diagnosis of sarcoma
- Diagnosis in a French Comprehensive Cancer Center
- Any age
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with sarcoma
Patients with a sarcoma diagnosed in a French Comprehensive cancer Center
|
treatment as per standard of care
treatment as per standard of care
treatment as per standard of care
treatment as per standard of care
treatment as per standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to next treatment (TNT)
Time Frame: 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.
|
2 years
|
|
Time to next treatment (TNT)
Time Frame: 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.
|
5 years
|
|
Overall survival (OS)
Time Frame: 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.
|
2 years
|
|
Overall survival (OS)
Time Frame: 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.
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Maud Toulmonde, MD, Institut Bergonié, Bordeaux, France
- Study Chair: Axel Le Cesne, MD/PhD, Institut Gustave Roussy, Villejuif, FRANCE
- Study Chair: Jean-Yves Blay, MD/PhD, Centre Léon Bérard, Lyon, France
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IB2012-BCB-SARCOMES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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