Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients
The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.
|Study Design:||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|
|Study Completion Date:||February 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
|Late stage endometrial cancer||
Chemoresponse Marker Assay
Other Name: ChemoFx
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.
|United States, Pennsylvania|
|Precision Therapeutics, Inc.|
|Pittsburgh, Pennsylvania, United States, 15203|
|Study Chair:||Holly Gallion, MD||Vice President, Clinical Affairs|