A test to assess cancer risk in women with ovarian masses before surgery
Validation of Ovarian Adnexal Mass Assessment Score Test System
This study is testing a new blood test to see if it can help women with ovarian masses find out if they have cancer before they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cleo Diagnostics Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 8 sites (Chandler, Arizona and 7 other locations) |
| Trial ID | NCT06566716 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of the CleoDX Ovarian Adnexal Mass Score Test System, which uses five blood biomarkers to differentiate between benign and malignant ovarian conditions. The test aims to provide a more accurate pre-surgical assessment of cancer risk for women with ovarian cysts or adnexal masses that require surgery. By improving the diagnostic process, the test could assist healthcare providers in making better-informed decisions regarding patient care and surgical interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who have an ovarian cyst or adnexal mass requiring surgery but have not yet undergone the procedure.
Not a fit: Patients with a prior confirmed diagnosis of ovarian cancer or those who have undergone treatment for gynecological malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to earlier and more accurate diagnoses of ovarian cancer, potentially improving patient outcomes.
How similar studies have performed: Initial studies have shown that this test outperforms the current standard test, CA125, indicating a promising approach to cancer risk assessment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandler, Arizona and 7 other locations
- New Horizons Clinical Trials — Chandler, Arizona, United States (Recruiting)
- Emerald Coast Clinical Research — Panama City, Florida, United States (Recruiting)
- Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (Recruiting)
- The Jackson Clinic — Jackson, Tennessee, United States (Recruiting)
- Next Innovative Clinical Research — Houston, Texas, United States (Recruiting)
- Prime Clinical Research - Lewisville — Lewisville, Texas, United States (Recruiting)
- Vast Clinical Research-Holy Cross — Mesquite, Texas, United States (Recruiting)
- Virginia Women's Health Associates — Annandale, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Assoc. Director of Operations Assoc. Director of Operations
- Email: cleo_csp01001@lindushealth.com
- Phone: 1-855-264-4064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.