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


N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Principal Investigator

Holly Gallion, MD

Investigator Role:

Study Director

Investigator Affiliation:

Vice President, Clinical Affairs

Authority:

United States: Institutional Review Board

Study ID:

PT-103

NCT ID:

NCT01048814

Start Date:

August 2009

Completion Date:

June 2011

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Precision Therapeutics, Inc.Pittsburgh, Pennsylvania  15203