Eligibility Module

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: 2025-12-25 @ 5:19 AM
Ignite Modification Date: 2025-12-25 @ 5:19 AM
NCT ID: NCT05624827
Eligibility Criteria: Inclusion Criteria: * Histologically confirmed CIN 2 (with biopsy of colposcopically suspicious changes in the cervix) * Age under 30 years * Satisfactory colposcopy (transformation zone fully visible) * Size of change below 75% of transformation zone * The change in the ectocervix is fully visible * Age 30-35 years, if the patient is non-smoker and the change in the cervix does not exceed 50% of the area of the transformation zone * Signing an informed consent to participate in the survey * Willingness to perform inspections every 6 months Exclusion Criteria: * Age 36 years or older * Unsatisfactory colposcopy (transformation zone not fully visible) * Size of change exceeds 75% of the transformation zone * The change in the ectocervix is not completely visible * Age 30-35 years for smokers or if the change exceeds 50% of the area of the transformation zone * Suspicted glandular precancerous changes * Histologically verified CIN 2 with cytological changes of glandular cells * Colposcopically suspected invasive disease * Histologically verified CIN 2 and histologically verified AIS * Histologically verified CIN 2 and histologically verified invasive cancer elsewhere in the cervix * Refusal to sign participation in the survey * Unwillingness to perform control examinations * Weakness of an immune system * Cervical conization performed in the past * Treatment with local immunomodulators
Healthy Volunteers: True
Sex: FEMALE
Minimum Age: 20 Years
Maximum Age: 36 Years
Study: NCT05624827
Study Brief:
Protocol Section: NCT05624827