Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Launched by CATHARINA ZIEKENHUIS EINDHOVEN · Jun 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well a treatment called imiquimod works for women with high-grade cervical lesions, specifically looking at the immune system's role in predicting treatment success. Imiquimod is a non-invasive option that may be particularly important for women who want to preserve their ability to become pregnant. While it can help many women, with 55-73% showing a complete response, some may experience side effects. The goal of this study is to find out if certain immune-related markers can help identify which patients are likely to benefit from imiquimod, thereby improving treatment effectiveness and reducing unnecessary side effects.

To participate in the trial, women must be at least 18 years old and have specific types of cervical lesions (CIN2 or CIN3) confirmed by a biopsy. Women who have had previous treatments or other certain medical conditions may not be eligible. If you join the study, you'll receive imiquimod treatment and be monitored for how well it works. The researchers hope to gather valuable information that could help future patients. If you're considering participating, it’s also important to discuss your options with your healthcare provider to understand what’s best for you.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Primary cHSIL lesions (e.g. CIN3 or CIN 2), histologically confirmed by diagnostic biopsy Nota bene: In case of CIN 2, expectative management must be discussed according to the Dutch national guideline with the patient, if the patient prefers imiquimod therapy the patient can be treated with imiquimod and enrolled in the study, if the patient prefers expectative management they can be enrolled in the observational CIN 2 group.
• • Recurrent or residual cHSIL lesions after initial LLETZ treatment (e.g. CIN2 or CIN3), histologically confirmed by diagnostic biopsy
• • Age of 18 years or older
• Exclusion Criteria:
• • Concomitant diagnoses of VAIN (vaginal intraepithelial neoplasia e.g. vaginal HSIL)
• • PAP (Papanicolaou) 4 cytology as indication for the baseline colposcopy at study entrance
• • Adenocarcinoma in situ (AIS) diagnosis
• • Previous imiquimod therapy for cHSIL
• • Previous cervical malignancy
• • Current malignant disease
• • Immunodeficiency (including HIV/AIDS and immunosuppressive medication)
• • Pregnancy
• • Legal incapability
• • Insufficient knowledge of the Dutch language