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

Endometrial Cancer Clinical Trial

Official title:

Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049126
• Other study ID #: PT-106
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: March 14, 2011
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: March 2011
• Source: Precision Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Other:
• ChemoFx
Chemoresponse Marker Assay

Locations

Country	Name	City	State
United States	Precision Therapeutics, Inc.	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Precision Therapeutics

Country where clinical trial is conducted

United States,