NCT06566716Active, not recruiting
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
Validation of Ovarian Adnexal Mass Assessment Score Test System
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 17 Aug 2024
- Start date
- 6 Sept 2024
- Primary completion date
- Feb 2027
- Lead sponsor
- Cleo Diagnostics Ltd
- Diseases
- Ovarian cancer
- NCT number
- NCT06566716
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 6 Sept 2024 to the primary completion date, Feb 2027
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other
- Pregnant currently or within the last 3 months based on participant self-report
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Women's Health Associates Coordinator of this site? Confirm its status | Annandale | United States | Unknown status |
| Dana-Farber Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| New Horizons Clinical Trials Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Duke University Medical Centre Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Next Innovative Clinical Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Women's Health Pavilion Coordinator of this site? Confirm its status | Howard Beach | United States | Unknown status |
| The Jackson Clinic Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Women's Cancer Center of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Maximos Ob/Gyn Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| Prime Clinical Research - Lewisville Coordinator of this site? Confirm its status | Lewisville | United States | Unknown status |
| Vast Clinical Research-Holy Cross Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Velocity Clinical Research - Annapolis Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| HCA Florida Physicians Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Emerald Coast Clinical Research Coordinator of this site? Confirm its status | Panama City | United States | Unknown status |
| Rush University Medical Centre Coordinator of this site? Confirm its status | Poughkeepsie | United States | Unknown status |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.