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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 25 Years to 45 Years |
| Sex | Women only |
| Enrollment | 96 (estimated) |
| Sponsor | Barretos Cancer Hospital Academic / other |
| Locations | 1 site (Barretos) |
| Status | Recruiting |
| Started | April 2, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT06356012 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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.