An interventional study of Blood-Based Ovarian Cancer Screening Test in Ovarian Cancer, sponsored by Mercy BioAnalytics, Inc.. Not yet recruiting at 2 sites in United States. Open to female participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Mercy BioAnalytics, Inc. · Not applicable, Interventional, and Screening
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.
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.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 1,750 is above the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →This is the only study on the registry with Mercy BioAnalytics, Inc. as lead sponsor.
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Exclusion Criteria:
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.
Diagnostic Test: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months following enrollment
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.
Time frame: 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.
Time frame: 12 months following enrollment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 257 interventional studies with no phase under Ovarian Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 18 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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