Identifying immune responses in women treated with imiquimod for cervical lesions
Immunophenotyping, Microbiome, Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients with High-grade Cervical Intraepithelial Lesions Treated with Imiquimod
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 |
| Enrollment | 96 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Barretos Cancer Hospital Academic / other |
| Locations | 1 site (Barretos) |
| Trial ID | NCT06356012 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 25 to 45 with a histological diagnosis of CIN 3 and high-risk HPV.
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.
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 performed: Previous studies have shown the efficacy of imiquimod in treating CIN lesions, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Barretos
- Barretos Cancer Hospital — Barretos, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.