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:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT04930159
Eligibility Criteria:
Inclusion Criteria:
1. Adult 18 years of age or older; and
2. Self-identify as Black/African American
3. Presenting with high-risk EC established by anatomic pathology as tumor stage and grade classification by the following:
1. Pathology documentation from any hospital/clinic/medical center, and
2. FIGO Stage 1A with Grade 2, Grade 3, or Grade 4 of any histology type or
3. FIGO Stage 1A with non-endometrioid (carcinosarcoma, serous, clear cell, undifferentiated or mixed) histology
4. FIGO Stage 1B, 2, 3, or 4 of any grade or histology
5. Recurrent endometrial cancer of any stage or grade
4. Documented provider recommendation and patient plan to initiate adjuvant therapy with chemotherapy, radiation, and/or immunotherapy.
Exclusion Criteria:
Participants must not have any of the following exclusion criteria:
1. Newly diagnosis of FIGO Stage IA Grade 1 endometrioid adenocarcinoma
2. Previous history of other cancer diagnosis requiring chemotherapy, radiation therapy, or immunotherapy within the past 12 months;
3. Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
4. Contraindication to all non-surgical therapy available for endometrial cancer (i.e., chemotherapy, radiation, and immunotherapy contraindicated);
5. Enrollment into hospice prior to randomization
6. Unable to provide written informed consent in English;
7. Unable to be contacted for research surveys;
8. Recent hospitalization for psychiatric illness in the past 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04930159
Study Brief:
Protocol Section:
NCT04930159