Ovarian Neoplasms
Conditions
Keywords
ovarian, adnexal, benign, malignant, cancer
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.
Interventions
DIAGNOSTIC_TESTCleoDX ovarian cancer test
A diagnostic test to assist in predicting risk of malignancy prior to surgery for patients with an adnexal mass.
Sponsors
Lindus Health
Cleo Diagnostics Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactAssoc. Director of Operations Assoc. Director of Operations
Backup ContactTrial Coordinator
Outcome results
None listed