Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Completed

• Conditions: Adnexal Mass; Ovarian Cancer

• Registration Number: NCT00987649
• Lead Sponsor: Fujirebio Diagnostics, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study Start: 2009-10
• Study First Posted: 2009-10-01
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-07
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 512

Inclusion Criteria

• 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 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
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone	Blood draw within 30 days of surgery

Trial Locations

Locations (13)

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

University of South Florida Medical Center; 🇺🇸 Tampa, Florida, United States

Women & Infants Hospital Rhode Island; 🇺🇸 Providence, Rhode Island, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Women's Clinic of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

OB/GYN Specialists of the Palm Beaches; 🇺🇸 Jupiter, Florida, United States

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States

Chattanooga GYN-ONCOLOGY; 🇺🇸 Chattanooga, Tennessee, United States

Jackson Clinic; 🇺🇸 Jackson, Tennessee, United States

Adams Patterson Gynecology & Obstetrics; 🇺🇸 Memphis, Tennessee, United States

Scripps Clinic Carmel Valley; 🇺🇸 San Diego, California, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States