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New Biomarkers Evaluating Ovarian Cancer

Sponsor
Fujirebio Diagnostics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01466049
Collaborator
(none)
280
Enrollment
2
Locations
27
Duration (Months)
140
Patients Per Site
5.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    280 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass
    Study Start Date :
    Dec 1, 2011
    Actual Primary Completion Date :
    Mar 1, 2014
    Actual Study Completion Date :
    Mar 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate novel biomarkers for patients with an adnexal mass [observational studies]

    Eligibility Criteria

    Criteria

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

    • Female, age 18 years or older

    • Adnexal mass present documented by imaging

    • Scheduled to undergo surgery based on a finding of adnexal mass

    • Able and willing to provide Informed Consent

    Exclusion Criteria:

    • Previous history of ovarian cancer

    • Previous history of bilateral oophorectomy

    • Currently known to be pregnant

    • Unable to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New Hanover Regional Medical Center Wilmington North Carolina United States 28402
    2 University of Oklahoma Oklahoma City Oklahoma United States 73110

    Sponsors and Collaborators

    • Fujirebio Diagnostics, Inc.

    Investigators

    • Study Director: Diana Dickson, Fujirebio Diagnostics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fujirebio Diagnostics, Inc.
    ClinicalTrials.gov Identifier:
    NCT01466049
    Other Study ID Numbers:
    • FDI-35
    First Posted:
    Nov 6, 2011
    Last Update Posted:
    Aug 5, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Fujirebio Diagnostics, Inc.
    Ovarian Cancer
    Adnexal Mass
    Pelvic Mass
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Aug 5, 2014