Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Completed

Conditions studied: Adnexal Mass, Ovarian Cancer

In brief

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 remove a pelvic mass. After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.

Key facts

Study ID

NCT00987649

Run by

Fujirebio Diagnostics, Inc.

People needed

512

Starts

2009-10-01

Expected to finish

2010-09-01

Last updated by the study team

2011-02-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous history of ovarian cancer
• Previous history of bilateral oophorectomy
• Currently known to be pregnant
• Unable to provide informed consent

Where it is running

• Scripps Clinic Carmel Valley — San Diego, California, United States
• Women's Clinic of Northern Colorado — Fort Collins, Colorado, United States
• OB/GYN Specialists of the Palm Beaches — Jupiter, Florida, United States
• University of South Florida Medical Center — Tampa, Florida, United States
• Woman's Hospital — Baton Rouge, Louisiana, United States
• Weill Medical College of Cornell University — New York, New York, United States
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Women & Infants Hospital Rhode Island — Providence, Rhode Island, United States
• Chattanooga GYN-ONCOLOGY — Chattanooga, Tennessee, United States
• Jackson Clinic — Jackson, Tennessee, United States
• Adams Patterson Gynecology & Obstetrics — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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