Predicting how well imiquimod treatment works for cervical lesions
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
This study is testing if certain immune markers can help predict how well the treatment imiquimod works for people with high-grade cervical lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Locations | 15 sites (Breda and 14 other locations) |
| Trial ID | NCT05405270 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed primary or recurrent cHSIL lesions.
Not a fit: Patients with concurrent diagnoses of vaginal intraepithelial neoplasia, previous cervical malignancy, or those with immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for women with cervical high-grade lesions, reducing unnecessary side effects.
How similar studies have performed: Other studies have shown promise in using biomarkers to predict treatment responses in similar conditions, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Breda and 14 other locations
- 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)
- Leiden Universitair Medisch Centrum — Leiden, Netherlands (Not_yet_recruiting)
- Maastricht Universitair Medisch Centrum — Maastricht, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
- Erasmus Medisch Centrum — Rotterdam, Netherlands (Recruiting)
- Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (Recruiting)
- HagaZiekenhuis — The Hague, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Recruiting)
- Máxima MC — Veldhoven, Netherlands (Recruiting)
- VieCuri Medisch Centrum — Venlo, Netherlands (Recruiting)
- Isala — Zwolle, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.