New Biomarkers Evaluating Ovarian Cancer

Completed

• Conditions: Adnexal Mass

• Registration Number: NCT01466049
• Lead Sponsor: Fujirebio Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Study Start: 2011-12
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate novel biomarkers for patients with an adnexal mass	observational studies

Trial Locations

Locations (2)

New Hanover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States