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Trial Title:
Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod
NCT ID:
NCT06356012
Condition:
HSIL, High-Grade Squamous Intraepithelial Lesions
Vaginal Microbiome
Biomarkers
Conditions: Official terms:
Squamous Intraepithelial Lesions of the Cervix
Carcinoma, Squamous Cell
Carcinoma in Situ
Imiquimod
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Imiquimod
Description:
Experimental group will be treated with 16 applications of imiquimod and subsequently
LEEP.
Arm group label:
Imiquimod treatment plus Loop Electrosurgical Excision Procedure
Other name:
IXIUM
Intervention type:
Procedure
Intervention name:
Loop Electrosurgical Excision Procedure
Description:
Active comparator group will be treated with LEEP.
Arm group label:
Imiquimod treatment plus Loop Electrosurgical Excision Procedure
Arm group label:
Loop Electrosurgical Excision Procedure
Other name:
LEEP
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.
Detailed description:
INTRODUCTION: High-grade intraepithelial lesions (CIN 2/3) are considered precursor
lesions of cervical cancer, and its treatment involves destructive or excisional methods.
Some studies have proven the efficacy of the immunomodulator imiquimod as a topical
treatment for CIN 2/3 lesions. Imiquimod activates the innate immune response through
dendritic cells, monocytes and macrophages, in addition to modulating the response
pattern of T lymphocytes. Thus, the characterization of the immune response in the
treatment with imiquimod in lesions caused by oncogenic HPV, may benefit women in a way
that it is possible to measure the response of each patient, improving the understanding
of its mechanism of action, directly impacting the efficacy and adverse events. caused by
the drug. OBJECTIVES: 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. MATERIALS AND METHODS: It will be included 90
patients, 60 with high-risk HPV, diagnosed with CIN 3 and 30 patients with negative
cytology and HPV. Patients will be divided into 3 groups: 1) patients with CIN 3 who will
use 16 doses of imiquimod in the uterine cervix, applied twice a week; 2) patients with
CIN 3 who will undergo standard treatment with Transformation Zone Excision (EZT); 3)
patients with negative cytology and HPV. Blood and cervicovaginal lavage will be
collected for immunophenotypic analysis (flow cytometry), quantification of immunological
mediators (Cytometric Bead Array) and evaluation of the microbiome (MiniION). The results
obtained will be correlated with the clinical and pathological data of the patients.
Criteria for 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
Gender:
Female
Minimum age:
25 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
April 2, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Barretos Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Agency class:
Other
Collaborator:
Agency:
Farmoquimica S.A.
Agency class:
Industry
Collaborator:
Agency:
Hospital de Cancer de Barretos - Fundacao Pio XII
Agency class:
Other
Source:
Barretos Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356012
