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| Name | Class |
|---|---|
| French Sarcoma Group | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment | 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 | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
-
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advanced soft tissue sarcoma
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| Name | Affiliation | Role |
|---|---|---|
| Antoine Italiano, MD/PhD | Institut Bergonié, Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié, Comprehensive Cancer Center | Bordeaux | France | ||||
| Centre Léon Bérard, Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28391775 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 | Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 | Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Time to Next Treatment (TNT) and Overall Survival (OS) Under First-line Treatment | 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 | Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 and satisfying all eligibility criteria | Posted | Number | 95% Confidence Interval | correlation coefficient | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Metastatic Softtissue Sarcomas Diagnosed Between 1990 and 2013 | Patients with metastatic softtissue sarcomas diagnosed between 1990 and 2013 satisfying all eligibility criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Antoine Italiano | Institut Bergonié | 33 5 56 33 33 33 | a.italiano@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009385 | Neoplastic Processes |
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| Lyon |
| France |
| Institut Gustave Roussy, Comprehensive Cancer Center | Villejuif | France |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 2,165 |
| 0 |
| 2,165 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |