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

Sponsor
Precision Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01048814
Collaborator
(none)
512
Enrollment
1
Location
22
Duration (Months)
23.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ChemoFx

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
512 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Study to Develop a Training Set for a Cross Validated Chemoresponse Marker Algorithm in Cases With Ovarian, Peritoneal or Fallopian Tube Cancer
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Ovarian, Peritoneal, Fallopian Cancer

Recurrent, Peristent or Refractory

Other: ChemoFx
Chemoresponse Marker Assay

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Precision Therapeutics, Inc. Pittsburgh Pennsylvania United States 15203

    Sponsors and Collaborators

    • Precision Therapeutics

    Investigators

    • Study Director: Holly Gallion, MD, Vice President, Clinical Affairs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01048814
    Other Study ID Numbers:
    • PT-103
    First Posted:
    Jan 14, 2010
    Last Update Posted:
    Jun 3, 2011
    Last Verified:
    Jun 1, 2011
    Additional relevant MeSH terms:
    Fallopian Tube Neoplasms

    Study Results

    No Results Posted as of Jun 3, 2011