Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Imiquimod is a good non-invasive treatment option for women with cervical high-grade squamous intraepithelial neoplasia (cHSIL), especially those with a possible (future) pregnancy wish. Complete response to imiquimod occurs in 55-73% of patients, however side-effects of imiquimod are common and can be extensive. Therefore, biomarkers which can predict response to imiquimod therapy are warranted, to increase therapy efficacy and to avoid side effects in patients who will not respond. This prospective, multi-center cohort study aims to validate the potential of immune related biomarkers to predict the clinical response of patients with primary cHSIL to imiquimod, aims to explore the value of these immune biomarkers in recurrent/residual cHSIL to predict treatment responses for imiquimod and aims to explore their potential in spontaneous regression of cHSIL (CIN2).

NCT Number	NCT05405270
Lead Sponsor	Catharina Ziekenhuis Eindhoven Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, Stichting Olijf: Dutch patient association for women with gynaecological cancer, Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology, Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology, Erasmus Medisch Centrum: Department of Gynaecology, Radboud Medisch Centrum: Department of Gynaecology
Conditions	Cervical High Grade Squamous Intraepithelial Lesion, Cervical Intraepithelial Neoplasia Grade 2/3, CIN 2/3, Cervical Intraepithelial Neoplasia
Enrollment	410 participants
Start Date	2022-06-01
Primary Completion	2024-12 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2023-09-11