New Biomarkers Evaluating Ovarian Cancer

Fujirebio Diagnostics

Status: Completed

Conditions: Adnexal Mass

Study type: Observational

Funder types: Industry

Identifiers

NCT01466049

FDI-35

Details and patient eligibility

About

The purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the ROMA algorithm for post-market benefits.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, age 18 years or older
• Adnexal mass present documented by imaging
• Scheduled to undergo surgery based on a finding of adnexal mass
• Able 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