Immunophenotyping, Microbiome, Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients with High-grade Cervical Intraepithelial Lesions Treated with Imiquimod

What this Trial Is About

This trial focuses on women aged 25 to 45 with high-grade cervical intraepithelial lesions (CIN 3) caused by high-risk HPV. Researchers aim to understand the local immune response, cervicovaginal environment, and microbiological profiles in these patients when treated with the immunomodulator imiquimod. The study compares the immune effects of imiquimod to the standard Loop Electrosurgical Excision Procedure (LEEP), also including a healthy group for comparison. Participants are divided into three groups: one group receives 16 doses of imiquimod applied to the cervix twice a week followed by LEEP; the second undergoes standard LEEP treatment alone; the third group consists of healthy women with negative cytology and HPV tests. Blood and cervicovaginal samples are collected at multiple times for immunophenotyping, immune mediator analysis, and microbiome evaluation. Throughout the study, researchers monitor immune responses and lesion changes by analyzing histological samples and immune markers during and after treatment. The main outcome is the number of patients showing histological regression of high-grade lesions over three years. The study also investigates correlations between vaginal microbiome changes and immune responses, with all participants followed for up to three years to assess these outcomes and safety.

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