RecruitingPhase 4NCT06356012

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

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


Sponsor

Barretos Cancer Hospital

Enrollment

96 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Imiquimod and Loop Electrosurgical Excision Procedure for people with biomarkers, hsil, high grade squamous intraepithelial lesions, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 25 Years to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImiquimod

Experimental group will be treated with 16 applications of imiquimod and subsequently LEEP.

PROCEDURELoop Electrosurgical Excision Procedure

Active comparator group will be treated with LEEP.


Locations(1)

Barretos Cancer Hospital

Barretos, Brazil

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NCT06356012


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