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

Launched by BARRETOS CANCER HOSPITAL · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system responds to a treatment called imiquimod in women with a condition known as high-grade cervical squamous intraepithelial lesions (CIN 3). The researchers want to learn more about the local immune response and the vaginal microbiome, which is the community of bacteria and other microorganisms in the vagina. Participants will be divided into three groups: one group will receive imiquimod treatment, another group will have a standard surgical procedure called LEEP, and the third group will include women with normal test results.

To be eligible for the trial, women need to be between 25 and 45 years old, carry high-risk HPV (a virus linked to cervical cancer), and live within 300 kilometers of Barretos, São Paulo. Participants will undergo several tests, including blood and cervicovaginal fluid collection, to monitor their immune response during the study. It's important to note that women who are pregnant, breastfeeding, or have certain health conditions may not qualify for the trial. If you're interested in participating or want to learn more, feel free to ask your healthcare provider.

Gender

FEMALE

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