NCT03837678

Epithelioid Sarcoma Natural History Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 74 (actual)
• Sponsor: Epizyme, Inc. · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Epithelioid Sarcoma

Timeline

• Start date: 2018-06-04
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2019-02-12
• Last updated: 2024-03-07

Locations

5 sites across 1 country: United States