NCT06356012 Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
| NCT ID | NCT06356012 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Barretos Cancer Hospital |
| Condition | HSIL, High-Grade Squamous Intraepithelial Lesions |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 96 participants in total. It began in 2024-04-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT06356012 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 45 Years, studying HSIL, High-Grade Squamous Intraepithelial Lesions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06356012 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06356012 currently recruiting?
Yes, NCT06356012 is actively recruiting participants. Visit ClinicalTrials.gov or contact Barretos Cancer Hospital to inquire about joining.
Where is the NCT06356012 trial being conducted?
This trial is being conducted at Barretos, Brazil.
Who is sponsoring the NCT06356012 clinical trial?
NCT06356012 is sponsored by Barretos Cancer Hospital. The trial plans to enroll 96 participants.