Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

Completed

• Conditions: Endometrial Cancer
• Interventions: Other: ChemoFx

• Registration Number: NCT01049126
• Lead Sponsor: Precision Therapeutics

Brief Summary

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

Detailed Description

This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-10
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Study Completion: 2010-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-14
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.
• Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).
• Case has been identified for pattern of response evaluation.
• Case must have a commercial ChemoFx drug response marker final report.

Exclusion Criteria

• Cases of patients who were deceased prior to 1 cycle of chemotherapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late stage endometrial cancer	ChemoFx	-

Trial Locations

Locations (1)

Precision Therapeutics, Inc.; 🇺🇸 Pittsburgh, Pennsylvania, United States