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

RecruitingPhase 4Ages 25 Years - 45 YearsFemaleBarretos Cancer Hospital
NCT06356012 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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); * Acceptance of the Informed Consent Form. Exclusion Criteria: * 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; * Who have been immunized for HPV; * Have used antibiotics in the last 30 days
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What it tests

  • Imiquimod
  • Loop Electrosurgical Excision Procedure
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Where

1 site
Barretos Cancer Hospital
Barretos, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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