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

This study has been completed.
Sponsor:
Information provided by:
Precision Therapeutics
ClinicalTrials.gov Identifier:
NCT01049126
First received: January 13, 2010
Last updated: March 14, 2011
Last verified: March 2011

January 13, 2010
March 14, 2011
July 2009
October 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01049126 on ClinicalTrials.gov Archive Site
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Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients
Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

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.

Endometrial Cancer
Other: ChemoFx
Chemoresponse Marker Assay
Other Name: ChemoFx
Late stage endometrial cancer
Intervention: Other: ChemoFx
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
February 2010
October 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01049126
PT-106
No
Holly Gallion, MD, Precision Therapeutics
Precision Therapeutics
Not Provided
Study Chair: Holly Gallion, MD Vice President, Clinical Affairs
Precision Therapeutics
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP