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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorBarretos Cancer Hospital

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

96 Participants
are divided into 3 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