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

NCT06356012 | Recruiting Phase 4 DMC

• 1 other identifier: 71163523.1.0000.5437
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL)

  A satisfactory immunological response is expected after the application of the immunomodulator imiquimod twice a week for 8 weeks in patients with CIN 3, with the objective of histological regression of the high squamous intraepithelial lesion (HSIL), which will be confirmed histologically after performing the gold standard LEEP treatment, which will be made available to all patients with CIN 3 included in the study

  3 years

Secondary Outcomes (1)

• Correlation between vaginal microbiome and immunological response

  3 years

Study Arms (3)

Imiquimod treatment plus Loop Electrosurgical Excision Procedure

EXPERIMENTAL

36 patients diagnosed with CIN 3 who will be undergone 16 applications of 5g imiquimod twice a week and then Loop Electrosurgical Excision Procedure will procedure (60 days). Pathological analysis will evaluate the lesion histologically after immunomodulatory treatment. The individual's immunological response will also be evaluated during applications and after surgical intervention.

Drug: Imiquimod; Procedure: Loop Electrosurgical Excision Procedure

Loop Electrosurgical Excision Procedure

ACTIVE COMPARATOR

30 patients diagnosed with CIN 3 who will be undergone Loop Electrosurgical Excision Procedure (60 days). Pathological analysis will evaluate the lesion histologically after treatment (LEEP). The individual's immunological response will also be evaluated after surgical intervention.

Procedure: Loop Electrosurgical Excision Procedure

healthy population

NO INTERVENTION

Immunological markers will be evaluated in a healthy population that had negative screening tests for cervical lesions to compare to the population in the injury and intervention groups.

Interventions

Imiquimod DRUG

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

Also known as: IXIUM

Imiquimod treatment plus Loop Electrosurgical Excision Procedure

Loop Electrosurgical Excision Procedure PROCEDURE

Active comparator group will be treated with LEEP.

Also known as: LEEP

Imiquimod treatment plus Loop Electrosurgical Excision Procedure; Loop Electrosurgical Excision Procedure

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Farmoquimica S.A.: collaborator
• Hospital de Cancer de Barretos - Fundacao Pio XII: collaborator

Study Sites (1)

Barretos Cancer Hospital

Barretos, Brazil

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: April 10, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 5, 2025

Record last verified: 2024-04

Locations

BR (1)