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Brief Title: Ovarian Cancer Risk Estimation in Patients With Pelvic Mass
Official Title: Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass
Study ID: NCT00987649
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Richard Moore, MD, FACOG, FACS
Affiliation: Women & Infants Hospital Rhode Island
Role: PRINCIPAL_INVESTIGATOR