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).
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
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
Catharina Ziekenhuis Eindhoven
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Stichting Olijf: Dutch patient association for women with gynaecological cancer
Collaborator
Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology
Collaborator
Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology
Collaborator
Erasmus Medisch Centrum: Department of Gynaecology
Collaborator
Radboud Medisch Centrum: Department of Gynaecology
Collaborator