NCT06566716

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

Validation of Ovarian Adnexal Mass Assessment Score Test System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Cleo Diagnostics Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CleoDX ovarian cancer test	A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.

Timeline

• Start date: 2024-09-06
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2024-08-22
• Last updated: 2025-02-04

Locations

8 sites across 1 country: United States