← Back to Search

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

N/A

Recruiting

Research Sponsored by Cleo Diagnostics Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Ovarian Cancer
Ovarian Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.