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| Name | Class |
|---|---|
| Analysis Group, Inc. | INDUSTRY |
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This study is a multi-center, non-interventional retrospective medical records review. The study will involve identification of medical records of patients with confirmed locally advanced unresectable or metastatic ES, who initiated systemic therapy between January 1, 2000 and December 31, 2017.
Data for the chart review will be extracted retrospectively from eligible subjects' charts (electronic or paper). Information on prior surgical treatment and neoadjuvant/adjuvant therapies for ES will also be collected for ineligible subjects with a locally advanced or metastatic ES diagnosis who did not initiated systemic therapy. Data collected will be anonymized by the investigators and will not be traceable back to individual subjects by the sponsor (i.e., no protected health information [PHI] will be collected).
The sampling period will span from January 1, 2000 to December 31, 2017. As the chart abstraction dates may be different across institutions due to contracting and other logistical issues, to avoid seeing biased outcomes that may be related to this type of heterogeneity, a consistent study end date will be imposed for all patients when conducting the analysis. Information before this study end date will be analyzed and used to conduct the analysis.
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| Measure | Description | Time Frame |
|---|---|---|
| Real-word overall response rate (rwORR) | Proportion of patients who have a documented radiological scan showing clinician-assessed complete response or less-than-complete response, of any duration, defined for each regimen and by line | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure |
| Real-world duration of response (rwDOR) | Duration of time between the first radiological scan showing documented tumor response (any time of response excluding SD) to first noted disease progression, or treatment discontinuation if no progression occurred. This is defined for each line of therapy and by regimen. | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Time from treatment initiation to treatment discontinuation | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure | |
| Time from treatment initiation to treatment failure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: Occurrence of adverse events | Occurrence of adverse events resulting in treatment modification or discontinuation, or patient hospitalization, while on systemic therapy | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 treatment modification or discontinuation |
Inclusion Criteria:
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The study population will consist of Epithelioid Sarcoma (ES) patients (approximately 70 to 100) from approximately five (5) academic centers (i.e., study sites) in the US. The sampling period will span from January 1, 2000 to December 31, 2017.
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Denver | Colorado | 80045 | United States | ||
| Dana Farber Cancer Institute |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants. Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
| Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure |
| Real-world disease control rate (rwDCR) | Proportion of patients who have documented radiological scans showing clinician-assessed complete response or less-than-complete response, or stable disease lasting at least 32 weeks | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure |
| Overall survival (OS) | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to death |
| Real-world time to tumor progression (rwTTP) | Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to tumor progression |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77054 | United States |