Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT06566716
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06566716
Study Brief:
Protocol Section:
NCT06566716