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METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa (METASARC)
Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.
The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.
Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS.
Prognostic factors of OS will be investigated.
| Condition or disease |
|---|
| Sarcoma Metastases Chemotherapy |
| Study Type : | Observational |
| Actual Enrollment : | 2165 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study |
| Actual Study Start Date : | January 1, 1990 |
| Actual Primary Completion Date : | January 1, 2017 |
| Actual Study Completion Date : | January 1, 2017 |
| Group/Cohort |
|---|
| patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 |
- Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment [ Time Frame: 2 years ]
TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
OS: time from the systemic treatment onset to death
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- advanced soft tissue sarcoma
- age > 18
Exclusion Criteria:
-
| France | |
| Institut Bergonié, Comprehensive Cancer Center | |
| Bordeaux, France | |
| Centre Léon Bérard, Comprehensive Cancer Center | |
| Lyon, France | |
| Institut Gustave Roussy, Comprehensive Cancer Center | |
| Villejuif, France | |
| Principal Investigator: | Antoine Italiano, MD/PhD | Institut Bergonié, Comprehensive Cancer Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 23, 2019 | ||||
| First Posted Date | June 6, 2019 | ||||
| Results First Submitted Date | November 25, 2020 | ||||
| Results First Posted Date | December 21, 2020 | ||||
| Last Update Posted Date | January 25, 2021 | ||||
| Actual Study Start Date | January 1, 1990 | ||||
| Actual Primary Completion Date | January 1, 2017 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment [ Time Frame: 2 years ] TNT: time from the systemic treatment onset to the next treatment or death due to any cause, whichever came first.
OS: time from the systemic treatment onset to death
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| Original Primary Outcome Measures |
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| 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 | METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa | ||||
| Official Title | Patterns of Care and Outcomes of Patients With METAstatic Soft Tissue SARComa in a Real-life Setting: the METASARC Observational Study | ||||
| Brief Summary |
Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals. The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug. Outcome (time-to-next treatment [TNT] and overall survival [OS]) will be reported according to histological subtype, as well as the association between TNT and OS. Prognostic factors of OS will be investigated. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | advanced soft tissue sarcoma | ||||
| Condition |
|
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 | ||||
| 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, Honoré C, Sargos P, Sunyach MP, Le Péchoux 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. | ||||
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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 | Completed | ||||
| Actual Enrollment |
2165 | ||||
| Original Estimated Enrollment |
3000 | ||||
| Actual Study Completion Date | January 1, 2017 | ||||
| Actual Primary Completion Date | January 1, 2017 (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 | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03977818 | ||||
| Other Study ID Numbers | IB2017-METASARC | ||||
| 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 | December 2020 | ||||
