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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOARA: Safety in Ovarian Cancer for Average-Risk Women - Analysis Clinical Validation Protocol
- ClinicalTrials.gov ID
- NCT07872644
- Acronym / sponsor ID
- SOARA / CS-3
- Conditions
- Ovarian Cancer
- Keywords
- Cancer Screening, Early Detection, Ovary, Liquid Biopsy, Evident, Safety, Screening, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- Mercy BioAnalytics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Average-Risk | Experimental | Diagnostic Test: Blood-Based Ovarian Cancer Screening TestPostmenopausal 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood-Based Ovarian Cancer Screening 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. | Diagnostic test | Average-Risk |
Primary outcome
Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events
Time frame: 12 months following enrollment
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.
Specificity of the Investigational Blood-Based Ovarian Cancer Screening Test
Time frame: 12 months following enrollment
Specificity will be assessed as the proportion of participants without ovarian cancer who receive a negative screening result during the study follow-up period.
Ratio of Invasive Follow-up Procedures to Confirmed Ovarian Cancer Diagnoses
Time frame: 12 months following enrollment
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.
2 secondary outcomes
Level of Participant-Reported Anxiety, Distress, and Cancer-Related Worry
Time frame: From positive test result through 12 months following enrollment
Nature and Severity of Complications Associated With Follow-up Diagnostic Evaluation
Time frame: 12 months following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Smith (781-609-7288, SOARAstudy@mercybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events (time frame: 12 months following enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.