NCT06566716 A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
| NCT ID | NCT06566716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cleo Diagnostics Ltd |
| Condition | Ovarian Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-09-06 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-09-06 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Assoc. Director of Operations Assoc. Director of Operations
✉ cleo_csp01001@lindushealth.com📞 1-855-264-4064
Chief Scientific Officer
STUDY DIRECTOR
Cleo Diagnostics Ltd
Frequently Asked Questions
Who can join the NCT06566716 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06566716 currently recruiting?
Yes, NCT06566716 is actively recruiting participants. Contact the research team at cleo_csp01001@lindushealth.com for enrollment information.
Where is the NCT06566716 trial being conducted?
This trial is being conducted at Chandler, United States, Panama City, United States, Las Vegas, United States, Jackson, United States and 4 additional locations.
Who is sponsoring the NCT06566716 clinical trial?
NCT06566716 is sponsored by Cleo Diagnostics Ltd. The principal investigator is Chief Scientific Officer at Cleo Diagnostics Ltd. The trial plans to enroll 1,000 participants.