Actively Recruiting
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
Led by Barretos Cancer Hospital · Updated on 2025-02-05
96
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
Sponsors
B
Barretos Cancer Hospital
Lead Sponsor
F
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 25 and 45 years of age (reproductive age)
- High-risk HPV carriers
- Residents less than 300 km from the city of Barretos-S�e3o Paulo
- Histological diagnosis of high-grade cervical squamous intraepithelial lesion (CIN 3) confirmed by colposcopy-guided biopsy at Barretos Cancer Hospital
- Acceptance of the Informed Consent Form
You will not qualify if you...
- Suspicion of invasive squamous cell carcinoma or adenocarcinoma (in situ or invasive) by colposcopy or cytology
- Pregnant or breastfeeding
- Immunodeficiency condition
- Previous treatment for high-grade cervical squamous intraepithelial lesion
- Immunized for HPV
- Use of antibiotics in the last 30 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Barretos Cancer Hospital
Barretos, Brazil
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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