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

NCT ID: NCT01048814

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 512 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-06-30

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ovarian, Peritoneal, Fallopian Cancer

Recurrent, Peristent or Refractory

ChemoFx

Intervention Type: OTHER

Chemoresponse Marker Assay

Interventions

ChemoFx

Chemoresponse Marker Assay

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Case has an original pathology report showing, epithelial ovarian, peritoneal, or fallopian tube carcinoma.
• Cases must meet one of the following classifications: Recurrent: Complete Response following primary therapy and a period of absence of no measurable disease; Persistent: Partial Response following 6 cycles of a platinum based therapy with measurable disease remaining or Refractory: Stable Disease or Progressive Disease during primary platinum therapy.
• Case must have a commercial ChemoFx drug response marker final report

Exclusion Criteria

• Cases with evidence of synchronous primary endometrial cancer or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: Stage not greater than I-B; Less than 3 mm invasion without vascular or lymphatic invasion; No poorly differentiated subtype, including papillary serous, clear cell, or other FIGO Grade 3 lesion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Precision Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Precision Therapeutics

Principal Investigators

Holly Gallion, MD

Role: STUDY_DIRECTOR

Vice President, Clinical Affairs

Locations

Precision Therapeutics, Inc.

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PT-103

Identifier Type: -

Identifier Source: org_study_id