Predicting how well imiquimod treatment works for cervical lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate immune-related biomarkers that can predict the response of patients with cervical high-grade squamous intraepithelial lesions (cHSIL) to imiquimod treatment. It will explore the effectiveness of these biomarkers in both primary and recurrent cases of cHSIL, as well as their potential role in spontaneous regression of cervical intraepithelial neoplasia (CIN2). The study involves multiple centers and includes various assessments, such as vaginal swabs for microbiome analysis, to gather comprehensive data on treatment responses. By identifying predictive biomarkers, the study seeks to enhance treatment efficacy and minimize side effects for patients who may not benefit from imiquimod therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Amphia
  Breda, Netherlands Recruiting
• Albert Schweitzer Ziekenhuis
  Dordrecht, Netherlands Recruiting
• Catharina Ziekenhuis Eindhoven
  Eindhoven, Netherlands Recruiting
• Tergooi MC
  Hilversum, Netherlands Recruiting
• Medisch Centrum Leeuwarden
  Leeuwarden, Netherlands Recruiting
• Maastricht Universitair Medisch Centrum
  Maastricht, Netherlands Recruiting

Study contacts

• Principal investigator: Edith Van Esch, MD, PhD — Catharina Ziekenhuis Eindhoven
• Study coordinator: Caroline Muntinga, MD
• Email: predict-topic@catharinaziekenhuis.nl
• Phone: 040 - 239 93 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.