Evaluation of CleoDX Ovarian Adnexal Mass Score Test for Cancer Risk in Women Needing Surgery

What this Trial Is About

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics CleoDX Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the tests accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the tests score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the tests ability to predict cancer risk accurately before surgery.

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