Brief Title
Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients
Official Title
Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer
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 Type
Observational
Condition
Endometrial Cancer
Intervention
ChemoFx
Study Arms / Comparison Groups
Late stage endometrial cancer
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
76
Start Date
July 2009
Completion Date
February 2010
Primary Completion Date
October 2009
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Holly Gallion, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01049126
Organization ID
PT-106
Study Sponsor
Precision Therapeutics
Study Sponsor
Holly Gallion, MD, Study Chair, Vice President, Clinical Affairs
Verification Date
March 2011