Ovarian CancerSOARANCT07872644
Safety in Ovarian Cancer for Average-Risk Women - Analysis
A study testing Blood-Based Ovarian Cancer Screening Test in people with Ovarian Cancer, run by Mercy BioAnalytics, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Blood-Based Ovarian Cancer Screening Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,750 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women with one or both ovaries
- Age 50 years or more
- No personal history of ovarian cancer
- No hereditary cancer syndrome of genetic risk factors associated with ovarian cancer
- Willingness to allow medical record review
- Willingness to have blood drawn
- Ability to provide informed consent
Who cannot join
- Removal of both ovaries for any reason
- Known genetic risk factors associated with ovarian cancer or hereditary cancer syndrome
- Pregnant or breastfeeding
- Currently under clinical surveillance due to a known or suspected elevated risk of developing ovarian cancer
- Women who are symptomatic and being evaluated for ovarian cancer
- Current untreated malignancy (other than non-melanoma skin cancer)
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- Currently receiving adjuvant chemotherapy or radiation therapy for cancer. Patients who are being treated may enroll 3 months after completion of last treatment.
- Anticoagulant use (self-reported)
- Known conditions posing unacceptable phlebotomy risk (self-reported)
- Unwilling to provide the name of primary care physician or provider
- Unwilling to sign informed consent and/or medical records release form.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
83Bar
Austin, Texas, 78759
571-712-8849
Mercy BioAnalytics, Inc.
Waltham, Massachusetts, 02451
Michael J Smith, SOARAstudy@mercybio.com
About this study
Official title: SOARA: Safety in Ovarian Cancer for Average-Risk Women - Analysis Clinical Validation Protocol
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.
Read the detailed description
This is a prospective, decentralized clinical study of the Evident Ovarian Cancer Screening Test in average-risk postmenopausal women aged 50 years and older. Between 1,000 and up to 1,750 participants will be enrolled. The study is intended to characterize the safety profile of the screening strategy, estimate test specificity, and evaluate the burden of downstream diagnostic procedures associated with positive screening results.
Eligible participants will complete informed consent procedures and undergo blood collection through a mobile phlebotomy service. Blood specimens will be analyzed using the Evident Ovarian Cancer Screening Test. Participants with negative screening results will not be required to undergo any further study procedures. Participants with positive screening results will be required to undergo transvaginal ultrasound (TVUS) and may elect to undergo additional Evident testing during follow-up. Clinical management decisions will remain under the direction of the participant's treating healthcare provider.
Clinical outcomes will be assessed through participant surveys, medical record review when available, and review of relevant imaging and diagnostic findings. Outcomes of interest include adverse events associated with the screening pathway, invasive diagnostic procedures, ovarian cancer diagnoses, and participant-reported psychological burden associated with positive screening results.
The primary objectives of the study are to evaluate the safety of the screening strategy, estimate the specificity of the Evident Ovarian Cancer Screening Test, and characterize the downstream procedural burden associated with positive test results in the intended-use population.
- Conditions
- Ovarian Cancer
- Being tested
- Blood-Based Ovarian Cancer Screening Test
- Keywords
- Cancer Screening, Early Detection, Ovary, Liquid Biopsy, Evident, Safety, Screening, Postmenopausal
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-Based Ovarian Cancer Screening TestDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Average-Risk | Experimental | 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. Receives: Diagnostic Test: Blood-Based Ovarian Cancer Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events
The proportion of participants experiencing one or more adverse events associated with the investigational ovarian cancer screening test, study procedures, or downstream clinical evaluation following a positive screening result.
Measured: 12 months following enrollment
Specificity of the Investigational Blood-Based Ovarian Cancer Screening Test
Specificity will be assessed as the proportion of participants without ovarian cancer who receive a negative screening result during the study follow-up period.
Measured: 12 months following enrollment
Ratio of Invasive Follow-up Procedures to Confirmed Ovarian Cancer Diagnoses
The burden of downstream diagnostic evaluation will be assessed by comparing the number of invasive follow-up procedures performed after positive screening results with the number of confirmed ovarian cancer diagnoses identified during the study period.
Measured: 12 months following enrollment
Secondary outcomes (2)
Level of Participant-Reported Anxiety, Distress, and Cancer-Related Worry
Participant-reported anxiety, distress, and cancer-related worry associated with positive screening results and follow-up evaluation.
Measured: From positive test result through 12 months following enrollment
Nature and Severity of Complications Associated With Follow-up Diagnostic Evaluation
The type, severity, seriousness, and clinical outcome of complications associated with diagnostic imaging, invasive diagnostic procedures, and surgical interventions undertaken in response to positive screening results.
Measured: 12 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mercy BioAnalytics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872644
- Sponsor's protocol ID
- CS-3
- Acronym
- SOARA
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No