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


N/A
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Principal Investigator

Holly Gallion, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vice President, Clinical Affairs

Authority:

United States: Institutional Review Board

Study ID:

PT-106

NCT ID:

NCT01049126

Start Date:

July 2009

Completion Date:

February 2010

Related Keywords:

  • Endometrial Cancer
  • Late Stage
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Precision Therapeutics, Inc.Pittsburgh, Pennsylvania  15203