About this trial
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.
Eligibility criteria
Qualifiers
Patients between 25 and 45 years of age (reproductive age);
High-risk HPV carriers;
Residents less than 300 km from the city of Barretos-São Paulo;
With a histological diagnosis of high-grade cervical squamous intraepithelial lesion (CIN 3), obtained through colposcopy-guided biopsy performed at the Barretos Cancer Hospital (HCB);
Disqualifiers
Suspicion of invasive squamous cell carcinoma or Adenocarcinoma (in situ or invasive) by colposcopy and/or cytology;
Pregnant or breastfeeding;
Immunodeficiency condition;
Previous treatment for high-grade cervical squamous intraepithelial lesion;
Trial design
Treatments tested in this trial
- Imiquimod
- Loop Electrosurgical Excision Procedure
Treatment groups
Sponsors and collaborators
Barretos Cancer Hospital
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
Farmoquimica S.A.
Collaborator
Hospital de Cancer de Barretos - Fundacao Pio XII
Collaborator