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_TESTA 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-RiskPostmenopausal 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
- Michael J Smith781-609-7288
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mercy BioAnalytics, Inc. | Waltham | Massachusetts | 02451 | Michael J Smith |
| 83Bar | Austin | Texas | 78759 | 571-712-8849 |
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