Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment

Plain-language summary

This study looks at whether the response to topical Imiquimod treatment can be predicted in patients with cervical intraepithelial neoplasia (CIN2/CIN3), also collecting vaginal microbiome samples. People aged 18 and older with histologically confirmed primary or recurrent lesions may take part. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Catharina Ziekenhuis Eindhoven

Intervention

Imiquimod, 3x vaginal swab for microbiome analysis, Expectative management, 2x vaginal swab for microbiome analysis

Start date

6/1/2022

Estimated completion

12/1/2026

Countries

Netherlands

Related genes

Locations

• Breda, Netherlands
• Dordrecht, Netherlands
• Eindhoven, Netherlands
• Hilversum, Netherlands
• Leeuwarden, Netherlands
• Leiden, Netherlands
• Maastricht, Netherlands
• Nijmegen, Netherlands
• Rotterdam, Netherlands
• Rotterdam, Netherlands
• The Hague, Netherlands
• Utrecht, Netherlands
• Veldhoven, Netherlands
• Venlo, Netherlands
• Zwolle, Netherlands

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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