A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Public ClinicalTrials.gov record NCT06566716. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Validation of Ovarian Adnexal Mass Assessment Score Test System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06566716
- Recruitment status
- Not listed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 5, 2024
- Primary completion
- Jul 31, 2025
- Completion
- Jul 31, 2026
- Last update posted
- Feb 3, 2025
2024 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| New Horizons Clinical Trials | Chandler | Arizona | 85224 | Recruiting |
| Emerald Coast Clinical Research | Panama City | Florida | 32405 | Recruiting |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89106 | Recruiting |
| The Jackson Clinic | Jackson | Tennessee | 38305 | Recruiting |
| Next Innovative Clinical Research | Houston | Texas | 77008 | Recruiting |
| Prime Clinical Research - Lewisville | Lewisville | Texas | 75067 | Recruiting |
| Vast Clinical Research-Holy Cross | Mesquite | Texas | 75149 | Recruiting |
| Virginia Women's Health Associates | Annandale | Virginia | 22003 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06566716, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06566716 live on ClinicalTrials.gov.