A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Recruiting now
Conditions studied: Ovarian Neoplasms
In brief
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.
Key facts
- Study ID
- NCT06566716
- Run by
- Cleo Diagnostics Ltd
- People needed
- 1000
- Starts
- 2024-09-06
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-02-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- female patients => 18 years of age at the time of consent
- Can provide written informed consent
- Have an ovarian cyst or adnexal mass (simple, complex, or solid ovarian/pelvic mass) identified through imaging examination (e.g. transvaginal ultrasound - TVU) that requires surgery, but have not yet undergone this surgery
You may not qualify if…
- Any prior confirmed diagnosis of, or treatment for, ovarian cancer
- Any prior surgery resulting in removal of both ovaries
- Prior history of gynecological malignancy (within last 2 years)
- Prior history of melanoma (within last 2 years)
- Prior treatment (within 12 months of sample collection) with chemotherapy, radiotherapy or immunotherapy
- Immune-compromised. Definition: those whose weakened immune system may render them more susceptible to infection, illness, or complications. These may include patients with immune-suppressive conditions (e.g. HIV/AIDS), patients undergoing immuno-, chemo- or radio-therapy (within the last 12 months) for any reason, receiving immune suppressive therapies (e.g. transplant recipients, individuals with known autoimmune disease), or with a primary immunodeficiency disorder (e.g. Lupus).
- Pregnant currently or within the last 3 months based on participant self-report
Where it is running
- New Horizons Clinical Trials — Chandler, Arizona, United States (enrolling)
- Emerald Coast Clinical Research — Panama City, Florida, United States (enrolling)
- Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (enrolling)
- The Jackson Clinic — Jackson, Tennessee, United States (enrolling)
- Next Innovative Clinical Research — Houston, Texas, United States (enrolling)
- Prime Clinical Research - Lewisville — Lewisville, Texas, United States (enrolling)
- Vast Clinical Research-Holy Cross — Mesquite, Texas, United States (enrolling)
- Virginia Women's Health Associates — Annandale, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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