Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Summary

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).

Conditions

• Cervical High Grade Squamous Intraepithelial Lesion
• Cervical Intraepithelial Neoplasia Grade 2/3
• CIN 2/3
• Cervical Intraepithelial Neoplasia

Interventions

DRUG

Imiquimod

Imiquimod 5% will be administered in the evening by either a vaginal applicator or administered on a vaginal tampon for three times a week during 16 weeks. Treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies, and at 6 months after completion of imiquimod therapy with cytology and if indicated histology.

DIAGNOSTIC_TEST

3x vaginal swab for microbiome analysis

A vaginal swab will be taken from all patients at inclusion (before start of imiquimod), at colposcopy 20 weeks after start of imiquimod and at 6 months after completion of imiquimod treatment during follow-up appointment.

OTHER

Expectative management

Expectative management of CIN 2 when preferred by the patient. Follow-up 6 months after baseline colposcopy with cytology and if indicated histology.

DIAGNOSTIC_TEST

2x vaginal swab for microbiome analysis

A vaginal swab will be taken from all patients at inclusion and at 6 months after inclusion during follow-up appointment.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Stichting Olijf: Dutch patient association for women with gynaecological cancer

  collaborator UNKNOWN

• Leids Universitair Medisch Centrum: Department of Medical Oncology and Department of Pathology

  collaborator UNKNOWN

• Maastricht Universitair Medisch Centrum: Department of Gynaecology and Department of Pathology

  collaborator UNKNOWN

• Erasmus Medisch Centrum: Department of Gynaecology

  collaborator UNKNOWN

• Radboud Medisch Centrum: Department of Gynaecology

  collaborator UNKNOWN

• Catharina Ziekenhuis Eindhoven

  lead OTHER

Principal Investigators

• Edith Van Esch, MD, PhD · Catharina Ziekenhuis Eindhoven

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-01

Primary Completion

2024-12-31

Completion

2026-12-31

Countries

• Netherlands

Study Locations