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Safety in Ovarian Cancer for Average-Risk Women - Analysis (SOARA)

SOARA: Safety in Ovarian Cancer for Average-Risk Women - Analysis Clinical Validation Protocol

Sponsor
Mercy BioAnalytics, Inc. (Industry)
Enrollment
1,750 planned
Conditions
Ovarian Cancer
Interventions
Blood-Based Ovarian Cancer Screening Test
Ages
adults, older adults
Registry
NCT07872644

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events
  • Specificity of the Investigational Blood-Based Ovarian Cancer Screening Test
  • Ratio of Invasive Follow-up Procedures to Confirmed Ovarian Cancer Diagnoses

History

  1. Primary completion expected

  2. Expected to start

  3. Last registry update

  4. Registered