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

NCT06356012 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-02-05

No results posted yet for this study

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.

Conditions

  • HSIL, High-Grade Squamous Intraepithelial Lesions
  • Vaginal Microbiome
  • Biomarkers

Interventions

DRUG

Imiquimod

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

PROCEDURE

Loop Electrosurgical Excision Procedure

Active comparator group will be treated with LEEP.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Farmoquimica S.A.

    collaborator INDUSTRY

  • Hospital de Cancer de Barretos - Fundacao Pio XII

    collaborator OTHER

  • Barretos Cancer Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356012 on ClinicalTrials.gov