Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 25 to 45 Women only

Identifying immune responses in women treated with imiquimod for cervical lesions

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

Run by Barretos Cancer Hospital · NCT06356012 · Data updated 2026-11-12

This study is testing how well the immune system responds to a cream called imiquimod in women with high-grade cervical lesions compared to those getting standard treatment or who have no lesions.

More Inflammation Biomarkers trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages25 Years to 45 Years
SexWomen only
Enrollment96 (estimated)
SponsorBarretos Cancer Hospital
Academic / other
Locations1 site (Barretos)
StatusRecruiting
StartedApril 2, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2028
Registry record updatedFebruary 5, 2025
Trial IDNCT06356012 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are women aged 25 to 45 with a histological diagnosis of CIN 3 and high-risk HPV.

Probably not a fit

Patients with invasive cervical cancer, those who are pregnant or breastfeeding, or those with immunodeficiency conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to characterize the immune response and microbiological profile in women diagnosed with high-grade cervical intraepithelial lesions (CIN 3) treated with imiquimod. Participants will be divided into three groups: those receiving imiquimod treatment, those undergoing standard excisional treatment, and those with negative cytology and HPV. Blood and cervicovaginal samples will be collected at various points to analyze the immune response to treatment. The study seeks to improve understanding of how imiquimod works and its effects on patients.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatments for women with high-grade cervical lesions.

How similar studies have gone: Previous studies have shown the efficacy of imiquimod in treating CIN lesions, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Barretos Cancer Hospital
    Barretos, Brazil
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.