A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Start Date
9/6/2024
Completion Date
8/1/2026
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CleoDX ovarian cancer test
Conditions
Locations
New Horizons Clinical Trials
Chandler, Arizona 85224
United States
Emerald Coast Clinical Research
Panama City, Florida 32405
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United States
The Jackson Clinic
Jackson, Tennessee 38305
United States
Next Innovative Clinical Research
Houston, Texas 77008
United States
Prime Clinical Research - Lewisville
Lewisville, Texas 75067
United States
Vast Clinical Research-Holy Cross
Mesquite, Texas 75149
United States
Virginia Women's Health Associates
Annandale, Virginia 22003
United States