Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod

The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients.

NCT Number	NCT06356012
Lead Sponsor	Barretos Cancer Hospital Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo, Farmoquimica S.A., Hospital de Cancer de Barretos - Fundacao Pio XII
Conditions	HSIL, High-Grade Squamous Intraepithelial Lesions, Vaginal Microbiome, Biomarkers
Enrollment	96 participants
Start Date	2024-04-02
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-05