RecruitingNCT06566716

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

Validation of Ovarian Adnexal Mass Assessment Score Test System


Sponsor

Cleo Diagnostics Ltd

Enrollment

1,000 participants

Start Date

Sep 6, 2024

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood-based diagnostic test to evaluate cancer risk before surgery in women who have an ovarian cyst or pelvic mass detected on ultrasound. The goal is to determine whether this test can help distinguish benign (non-cancerous) from malignant (cancerous) masses before the surgeon operates. **You may be eligible if...** - You are a woman aged 18 or older - You have an ovarian cyst or pelvic mass found on imaging that requires surgery, but have not yet had the surgery **You may NOT be eligible if...** - You have a prior confirmed diagnosis of ovarian cancer - You have had surgery that removed both ovaries - You have a history of gynecological cancer or melanoma within the past 2 years - You have received chemotherapy, radiation, or immunotherapy in the past 12 months - You have a weakened immune system (HIV/AIDS, on immunosuppressive drugs, or primary immune deficiency) - You are currently pregnant or have been pregnant in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCleoDX ovarian cancer test

A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.


Locations(8)

New Horizons Clinical Trials

Chandler, Arizona, United States

Emerald Coast Clinical Research

Panama City, Florida, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

The Jackson Clinic

Jackson, Tennessee, United States

Next Innovative Clinical Research

Houston, Texas, United States

Prime Clinical Research - Lewisville

Lewisville, Texas, United States

Vast Clinical Research-Holy Cross

Mesquite, Texas, United States

Virginia Women's Health Associates

Annandale, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06566716


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