An observational study in Epithelioid Sarcoma, sponsored by Epizyme, Inc.. Completed at 5 sites in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Epizyme, Inc. · Observational
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 74 is below the median of 121 across 238 observational studies indexed under Sarcoma.
Browse Sarcoma studies →Epizyme, Inc. is the lead sponsor of 21 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
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
Time frame: 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.
Time frame: 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 discontinuation
Time frame: 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
Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to tumor progression
Safety Outcome: Occurrence of adverse events
Occurrence of adverse events resulting in treatment modification or discontinuation, or patient hospitalization, while on systemic therapy
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 treatment modification or discontinuation
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Epizyme, Inc.