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

Completed

Conditions studied: Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

In brief

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.

Key facts

Study ID

NCT01048814

Run by

Precision Therapeutics

People needed

512

Starts

2009-08-01

Expected to finish

2011-06-01

Last updated by the study team

2011-06-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Precision Therapeutics, Inc. — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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