A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass

Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information

Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.

Time frame: Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.

Determine performance and accuracy of the CleoDX test against post-surgical pathology findings

Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.

Time frame: Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.

Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow

Demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements.

Time frame: Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first.