Safety in Ovarian Cancer for Average-Risk Women - Analysis

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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, downstream diagnostic procedures, and ovarian cancer outcomes.

Eligibility

Primary outcome measure(s)

• Incidence of Test-Related, Procedure-Related, and Screening-Related Adverse Events — 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 — 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 — 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.

Trial sites (2)

Other trials for the same condition