Status:
COMPLETED
Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Collaborating Sponsors:
Advanced Clinical Research Services, LLC
ReSearch Pharmaceutical Services, Inc.
Conditions:
Adnexal Mass
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to rem...
Eligibility Criteria
Inclusion
- Female, age ≥ 18 years
- Adnexal mass present documented by imaging
- Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
- Able to understand and willing to provide Informed Consent
Exclusion
- Previous history of ovarian cancer
- Previous history of bilateral oophorectomy
- Currently known to be pregnant
- Unable to provide informed consent
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT00987649
Start Date
October 1 2009
End Date
September 1 2010
Last Update
February 9 2011
Active Locations (13)
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1
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130
2
Women's Clinic of Northern Colorado
Fort Collins, Colorado, United States, 80524
3
OB/GYN Specialists of the Palm Beaches
Jupiter, Florida, United States, 33458
4
University of South Florida Medical Center
Tampa, Florida, United States, 33606