A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass (NCT06566716)
Validation of Ovarian Adnexal Mass Assessment Score Test System
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: New Horizons Clinical Trials — Chandler, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- CleoDX ovarian cancer test (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (8 Sites)
- New Horizons Clinical Trials — Chandler, Arizona
- Emerald Coast Clinical Research — Panama City, Florida
- Women's Cancer Center of Nevada — Las Vegas, Nevada
- The Jackson Clinic — Jackson, Tennessee
- Next Innovative Clinical Research — Houston, Texas
- Prime Clinical Research - Lewisville — Lewisville, Texas
- Vast Clinical Research-Holy Cross — Mesquite, Texas
- Virginia Women's Health Associates — Annandale, Virginia
📞 Contact the Study Coordinator
Phone: (855) 264-4064
Email: cleo_csp01001@lindushealth.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ovarian Neoplasms
- A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy — Tempe, Arizona
- A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer — Anchorage, Alaska
- BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer — Durham, North Carolina
- Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants — New York, New York
- Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer — Little Rock, Arkansas
- A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01) — Randwick, New South Wales
Explore by condition: All Ovarian Neoplasms clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.