Predicting Response In Cervical intraepithelial neoplasia to Topical Imiquimod treatment (PRedICT-TOPIC)

Recruiting

• Conditions: cervical high squamous intraepithelial lesion (cHSIL) / CIN; 10013364

• Registration Number: NL-OMON51652
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 410

Inclusion Criteria

- Primary cHSIL lesions (e.g. CIN3 or CIN 2), histologically confirmed by
diagnostic biopsy
NB: In case of CIN 2, <30 years, 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 arm.
- 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 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Confirm the relationship between a complete clinical response to imiquimod<br /><br>and the increased stromal infiltration of CD4+ T cells, CD11c+ cells and/or<br /><br>M1-like macrophages as well as the decreased infiltration with FoxP3+ Tregs in<br /><br>primary cHSIL.<br /><br>• Validate the association of a *hot signature*, defined as the sum of the<br /><br>numbers of stromal CD4+/CD11c+/M1+ cells per square millimeter minus the number<br /><br>of stromal FoxP3+ cells per square millimeter, with a complete response to<br /><br>imiquimod treatment in primary cHSIL.<br /><br>• Determine the sensitivity and specificity of the *hot signature* in patients<br /><br>with primary cHSIL lesions to estimate the predictive value for therapy<br /><br>efficacy upon imiquimod treatment.</p><br>