NCT01048814

Retrospective Case Study to Validate Existing Chemoresponse Marker Test in Ovarian, Peritoneal or Fallopian Cancer Cases

Retrospective Study to Develop a Training Set for a Cross Validated Chemoresponse Marker Algorithm in Cases With Ovarian, Peritoneal or Fallopian Tube Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 512 (estimated)
• Sponsor: Precision Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to improve upon and validate the prognostic and/or predictive accuracy of a drug response marker by the development of improved alternative algorithms based on the actual clinical outcome of retrospective cases.

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 512 cases will be collected from approximately 30 sites and correlated to the secondary endpoints identified in order to produce a training set that will incorporate additional improvements to the existing ChemoFx scoring system. 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.

Conditions

• Ovarian Cancer
• Peritoneal Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
OTHER	ChemoFx	Chemoresponse Marker Assay

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-01-14
• Last updated: 2011-06-03

Locations

1 site across 1 country: United States