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National Clinical and Biological Sarcoma Database : An Initiative of the French Sarcoma Group (BCB-Sarcomes)
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 |
|---|---|
| Sarcoma | Drug: Chemotherapy Drug: Immunotherapeutic Agent Drug: target treatment Procedure: Surgery Radiation: Radiotherapy |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 20000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 10 Years |
| 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 : | January 2010 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2025 |
- 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.
- 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.
- 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.
- 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.
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 5, 2019 | |||||||||
| First Posted Date | June 6, 2019 | |||||||||
| Last Update Posted Date | November 30, 2020 | |||||||||
| Actual Study Start Date | January 2010 | |||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | 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 | |||||||||
| 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]). |
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| Detailed Description | Not Provided | |||||||||
| Study Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 10 Years | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Sarcoma patients | |||||||||
| Condition | Sarcoma | |||||||||
| Intervention |
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| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
20000 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | December 2025 | |||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: - |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03978039 | |||||||||
| Other Study ID Numbers | IB2012-BCB-SARCOMES | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Institut Bergonié | |||||||||
| Study Sponsor | Institut Bergonié | |||||||||
| Collaborators | French Sarcoma Group | |||||||||
| Investigators |
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| PRS Account | Institut Bergonié | |||||||||
| Verification Date | November 2020 | |||||||||
