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Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
Sponsor: Barretos Cancer Hospital
Summary
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.
Official title: Immunophenotyping, Microbiome, Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients with High-grade Cervical Intraepithelial Lesions Treated with Imiquimod
Key Details
Gender
FEMALE
Age Range
25 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-04-02
Completion Date
2028-12-31
Last Updated
2025-02-05
Healthy Volunteers
Yes
Interventions
Imiquimod
Experimental group will be treated with 16 applications of imiquimod and subsequently LEEP.
Loop Electrosurgical Excision Procedure
Active comparator group will be treated with LEEP.
Locations (1)
Barretos Cancer Hospital
Barretos, Brazil