A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
NCT Number: NCT06566716
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ovarian Neoplasms
Interventions: DIAGNOSTIC_TEST: CleoDX ovarian cancer test
Sponsor: Cleo Diagnostics Ltd
Collaborators: Lindus Health
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2026-08
Locations: New Horizons Clinical Trials, Chandler, Arizona, 85224, United States|Zillan Clinical Research, Inglewood, California, 90303, United States|GYN Research Institute, Kissimmee, Florida, 34741, United States|Innovation Clinical Trials INC, Palmetto Bay, Florida, 33157, United States|Women's Cancer Center of Nevada, Las Vegas, Nevada, 89106, United States|ES Clinical Research Group LLC, Fresh Meadows, New York, 11365, United States|Vast Clinical Research-Holy Cross, Mesquite, Texas, 75149, United States

Summary:
Ovarian cancer is a serious health risk with the highest death rate among gynecological cancers. Unfortunately, it's only possible to definitively diagnose ovarian cancer after surgery, as there are no reliable tests to determine if an ovarian abnormality is cancerous or benign before surgery.

Cleo Diagnostics have developed a new test that uses five biomarkers in the blood to better differentiate between benign and malignant ovarian conditions. In initial studies, this test outperformed the current standard test, CA125, in identifying cancer.

This study aims to evaluate the effectiveness of the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This test measures five analytes in the blood and provides a score indicating the likelihood of cancer in patients with an adnexal mass requiring surgery. The test is designed to assist doctors in making better-informed decisions about surgery and patient care by providing a more accurate pre-surgical assessment of cancer risk. By doing so, it aims to improve patient outcomes and ensure that those with malignant conditions receive the appropriate specialist care.

Primary Outcome Measures: Calculation of the CleoDX adnexal mass score, Determine the Cleo Diagnostics (CleoDX) adnexal mass score in patients identified with an adnexal mass requiring surgery, but who have not yet undergone this surgery., 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.
Secondary Outcome Measures: 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., 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., 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., 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.