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Safety in Ovarian Cancer for Average-Risk Women - Analysis
Sponsor: Mercy BioAnalytics, Inc.
Summary
This study is designed to evaluate the safety, specificity, and downstream diagnostic burden of the Evident™ Ovarian Cancer Screening Test in average-risk postmenopausal women. Participants will provide a blood sample for screening and will be followed for approximately 12 months to assess test safety, specificity, downstream diagnostic procedures, and ovarian cancer outcomes.
Official title: SOARA: Safety in Ovarian Cancer for Average-Risk Women - Analysis Clinical Validation Protocol
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1750
Start Date
2026-11
Completion Date
2028-05
Last Updated
2026-10-13
Healthy Volunteers
Yes
Conditions
Interventions
Blood-Based Ovarian Cancer Screening Test
A blood sample will be collected and analyzed using an investigational blood-based ovarian cancer screening test. Participants with positive screening results will be advised to undergo follow-up transvaginal ultrasound (TVUS) and may elect repeat blood-based testing. Additional clinical evaluation is determined by their healthcare provider.
Locations (2)
Mercy BioAnalytics, Inc.
Waltham, Massachusetts, United States
83Bar
Austin, Texas, United States