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Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Recruitingn/aAges 18 Years - anyFemaleCatharina Ziekenhuis Eindhoven
NCT05405270 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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
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What it tests

  • Imiquimod
  • 3x vaginal swab for microbiome analysis
  • Expectative management
  • 2x vaginal swab for microbiome analysis
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Where

15 sites
Amphia
Breda, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Tergooi MC
Hilversum, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Leiden Universitair Medisch Centrum
Leiden, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Radboudumc
Nijmegen, Netherlands

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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