IRB Study Number 25-728
Status Recruiting
Locations Fairview Hospital, Hillcrest Hospital, Cleveland Clinic Main Campus
Institute Taussig Cancer Institute
Description
Primary Objectives
i. To 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;
ii. To 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;
iii. To demonstrate superiority of the CleoDX adnexal mass scoring system compared to standard clinical workflows including CA125 and Risk of Malignancy Index (RMI) measurements.
iv. To collect robust clinical performance data to support a 510(k) submission to the US Food and Drug Administration (FDA), demonstrating the effectiveness of the presurgical triage test for its intended use.
Inclusion Criteria
Are 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 (transvaginal ultrasound - TVU) that requires surgery, but has 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 (bilateral oophorectomy)
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.
