A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
- Conditions
- Ovarian Neoplasms
- Interventions
- Diagnostic Test: CleoDX ovarian cancer test
- Registration Number
- NCT06566716
- Lead Sponsor
- Cleo Diagnostics Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Malignant CleoDX ovarian cancer test Patients with an adnexal mass that is surgically diagnosed as malignant Non-Malignant CleoDX ovarian cancer test Patients with an adnexal mass that is surgically diagnosed as benign
- Primary Outcome Measures
Name Time Method Calculation of the CleoDX adnexal mass score Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first. Determine the Cleo Diagnostics (CleoDX) adnexal mass score in patients identified with an adnexal mass requiring surgery, but who have not yet undergone this surgery.
- Secondary Outcome Measures
Name Time Method Compare CleoDX adnexal mass score with pre- and post-surgical clinicopathologic information Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first. Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.
Identify rate of accurately predicted diagnoses by CleoDX compared to that of standard clinical workflow Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first. Demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements.
Determine performance and accuracy of the CleoDX test against post-surgical pathology findings Outcomes will be assessed during an analysis phase, which will commence after completion of patient recruitment and continue for up to 12 months or the end of the study period is reached (August 2026), whichever occurs first. Correlate post-surgical pathology findings with the CleoDX adnexal mass score, and evaluate the performance metrics (including sensitivity, specificity, Negative Predictive Value and Positive Predictive Value) of the CleoDX adnexal mass assessment scoring system.
Trial Locations
- Locations (8)
New Horizons Clinical Trials
🇺🇸Chandler, Arizona, United States
Emerald Coast Clinical Research
🇺🇸Panama City, Florida, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Next Innovative Clinical Research
🇺🇸Houston, Texas, United States
Prime Clinical Research - Lewisville
🇺🇸Lewisville, Texas, United States
Vast Clinical Research-Holy Cross
🇺🇸Mesquite, Texas, United States
Virginia Women's Health Associates
🇺🇸Annandale, Virginia, United States