Clinical trial

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

Name

71163523.1.0000.5437

Description

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.

Trial arms

Trial start

2024-04-02

Estimated PCD

2026-12-31

Trial end

2028-12-31

Status

Not yet recruiting

Phase

Early phase I

Treatment

Imiquimod

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

Arms:

Imiquimod treatment plus Loop Electrosurgical Excision Procedure

Other names:

IXIUM

Loop Electrosurgical Excision Procedure

Active comparator group will be treated with LEEP.

Arms:

Imiquimod treatment plus Loop Electrosurgical Excision Procedure, Loop Electrosurgical Excision Procedure

Other names:

LEEP

Size

Primary endpoint

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

3 years

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

Updated at

2024-04-10

1 organization

1 product

3 indications

Organization

Barretos Cancer Hospital

Product

Indication

Indication

Indication