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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT04574635
Eligibility Criteria:
Inclusion Criteria:
* Able to provide written consent
* Patient has given permission to give tumor/blood sample for research testing
* Histological confirmation of adenocarcinoma, adenosquamous, or small cell carcinoma of the cervix
* Known HPV status defined as positive staining for p16 on IHC or DNA ISH for HPV
* Willingness to return to enrolling institution (Mayo Clinic Rochester or the University of Minnesota) for follow-up (during the Active Monitoring Phase of the study) or complete blood draws locally using study mail-in kits
* Consent to allow blood specimens to be shared with Mayo Clinic study personnel and potential external collaborators for sample analysis
* Definitive Chemoradiotherapy for Locally Advanced Disease (FIGO Stage IB2-IIIC)
* FIGO 2019 Stage IB2-IIIC or not a surgical candidate
* Plan to undergo definitive chemoradiotherapy including external beam radiotherapy, brachytherapy, and chemotherapy
Exclusion Criteria:
* Other active malignancy =\< 2 years prior to registration.
* EXCEPTIONS: Non-melanotic skin cancer
* NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer
* Pregnancy or lactation
* Inability on the part of the patient to understand the informed consent to be compliant with the protocol
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04574635
Study Brief:
Protocol Section:
NCT04574635