Epithelioid Sarcoma Natural History Study

Epithelioid Sarcoma Natural History Study

Sponsors

Lead Sponsor: Epizyme, Inc.

Collaborator: Analysis Group, Inc.

Source Epizyme, Inc.
Brief 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.

Overall Status Active, not recruiting
Start Date June 4, 2018
Completion Date February 28, 2019
Primary Completion Date February 28, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Real-word overall response rate (rwORR) 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) Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Secondary Outcome
Measure 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 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) 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
Enrollment 74
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

- Diagnosed with histologically confirmed, locally advanced unresectable or metastatic Epithelioid Sarcoma (ES) requiring systemic therapy during between January 1, 2000 and December 31, 2017. The date of the confirmed locally advanced unresectable or metastatic ES diagnosis is designated as the index date.

- Patients may have a date of ES diagnosis at an earlier stage prior to 2000 and still be eligible for the study

- Initiation of treatment with any systemic anti-cancer therapy for the treatment of their locally advanced unresectable or metastatic ES between January 1, 2000 and December 31, 2017

- At least 10 years of age at the index date

Gender: All

Minimum Age: 10 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
University of Colorado Cancer Center | Denver, Colorado, 80045, United States
Dana Farber Cancer Institute | 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
Location Countries

United States

Verification Date

February 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Other

Time Perspective: Retrospective

Source: ClinicalTrials.gov