Safety in Ovarian Cancer for Average-Risk Women - Analysis

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
Mercy BioAnalytics, Inc.
Study ID
NCT07872644
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Blood-Based Ovarian Cancer Screening Test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Nov 30, 2026
Status verified
Oct 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
1,750 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Average-Risk
    Postmenopausal women aged 50 years or older with no known current ovarian cancer, other active malignancy, or established ovarian cancer risk factors. The study will aim to enroll a diverse population generally representative of the US population with respect to race and ethnicity.

Primary Outcome Measure

Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events [ Time Frame: 12 months following enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mercy BioAnalytics, Inc.WalthamMassachusetts02451
Michael J Smith
83BarAustinTexas78759
571-712-8849

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