New Biomarkers Evaluating Ovarian Cancer

August 4, 2014 updated by: Fujirebio Diagnostics, Inc.

Evaluation of New Biomarker Assays in Ovarian Cancer Patients Presenting to a Generalist With an Adnexal Mass

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Wilmington, North Carolina, United States, 28402
        • New Hanover Regional Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73110
        • University of Oklahoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with an adnexal mass, presenting to a general surgeon or obstetrician/ gynecologist at a general or specialty center within the United States, for whom a decision to proceed with surgery to remove the mass has been made.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate novel biomarkers for patients with an adnexal mass
Time Frame: observational studies
observational studies

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujirebio Diagnostics, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDI-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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