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A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
NCT06566716 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DIAGNOSTIC_TEST CleoDX ovarian cancer test
Study Locations (8)
Texas
- Next Innovative Clinical Research — Houston
- Prime Clinical Research - Lewisville — Lewisville
- Vast Clinical Research-Holy Cross — Mesquite
Arizona
- New Horizons Clinical Trials — Chandler
Florida
- Emerald Coast Clinical Research — Panama City
Nevada
- Women's Cancer Center of Nevada — Las Vegas
Tennessee
- The Jackson Clinic — Jackson
Virginia
- Virginia Women's Health Associates — Annandale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2024-09-06 |
| Est. Completion | 2026-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06566716
The ClinicalTrials.gov registry entry for NCT06566716 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cleo Diagnostics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which CleoDX ovarian cancer test is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06566716 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Texas, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06566716 about?
NCT06566716 is a clinical study titled "A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass". 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...
What is the current status of trial NCT06566716?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2024-09-06. Estimated completion is 2026-08.
What conditions does trial NCT06566716 study?
This clinical trial studies the following conditions: Ovarian Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06566716?
The interventions under investigation include: CleoDX ovarian cancer test (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06566716?
This trial is sponsored by Cleo Diagnostics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06566716 being conducted?
This trial has 8 study locations across Arizona, Florida, Nevada, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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