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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01049126
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : March 16, 2011
Information provided by:
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.

Condition or disease Intervention/treatment
Endometrial Cancer Other: ChemoFx

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 Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer
Study Start Date : July 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : February 2010

Group/Cohort Intervention/treatment
Late stage endometrial cancer Other: ChemoFx
Chemoresponse Marker Assay

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 70 cases of late stage endometrial cancer that have had ChemoFx drug response marker results from August 2007 to January 31, 2009 will be included.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01049126

United States, Pennsylvania
Precision Therapeutics, Inc.
Pittsburgh, Pennsylvania, United States, 15203
Sponsors and Collaborators
Precision Therapeutics
Study Chair: Holly Gallion, MD Vice President, Clinical Affairs

Responsible Party: Holly Gallion, MD, Precision Therapeutics Identifier: NCT01049126     History of Changes
Other Study ID Numbers: PT-106
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by Precision Therapeutics:
Late Stage

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female