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

ConditionsHSIL, High-Grade Squamous Intraepithelial LesionsVaginal MicrobiomeBiomarkers
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorBarretos Cancer Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imiquimod

    Drug

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

  • Loop Electrosurgical Excision Procedure

    Procedure/Surgery

    Active comparator group will be treated with LEEP.

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Imiquimod treatment plus Loop Electrosurgical Excision ProcedureExperimental treatment 2 interventions
Group B: Loop Electrosurgical Excision ProcedureActive comparator 1 intervention
Group C: healthy populationNo intervention 0 interventions

Trial outcomes

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

Time frame
3 years

Secondary outcomes

1

Correlation between vaginal microbiome and immunological response

Analysis of the vaginal microbiota and its correlation with the immunological response to imiquimod in CIN 3 lesions

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barretos Cancer Hospital

Lead sponsor

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

Farmoquimica S.A.

Collaborator

Hospital de Cancer de Barretos - Fundacao Pio XII

Collaborator

Source ClinicalTrials.gov
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