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Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

Sponsor
Precision Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01049126
Collaborator
(none)
76
Enrollment
1
Location
7.1
Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

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 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. 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. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Study Design

Study Type:
Observational
Actual Enrollment :
76 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Oct 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Late stage endometrial cancer

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 stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.

    • Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).

    • Case has been identified for pattern of response evaluation.

    • Case must have a commercial ChemoFx drug response marker final report.

    Exclusion Criteria:
    • Cases of patients who were deceased prior to 1 cycle of chemotherapy.

    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 Chair: Holly Gallion, MD, Vice President, Clinical Affairs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01049126
    Other Study ID Numbers:
    • PT-106
    First Posted:
    Jan 14, 2010
    Last Update Posted:
    Mar 16, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    Late Stage
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Mar 16, 2011