Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Fujirebio Diagnostics

Status: Completed

Conditions: Ovarian Cancer; Adnexal Mass

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00987649

FDI-15

Details and patient eligibility

About

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.

Enrollment: 512 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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