Status:
RECRUITING
A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women with an Ovarian Mass
Lead Sponsor:
Cleo Diagnostics Ltd
Collaborating Sponsors:
Lindus Health
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 6 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06566716
Start Date
September 6 2024
End Date
August 1 2026
Last Update
February 4 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
New Horizons Clinical Trials
Chandler, Arizona, United States, 85224
2
Emerald Coast Clinical Research
Panama City, Florida, United States, 32405
3
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
4
The Jackson Clinic
Jackson, Tennessee, United States, 38305