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

NCT06566716 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-02-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lindus Health

    collaborator INDUSTRY

  • Cleo Diagnostics Ltd

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Officer · Cleo Diagnostics Ltd

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06566716 on ClinicalTrials.gov