Actively Recruiting
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
Led by Catharina Ziekenhuis Eindhoven · Updated on 2023-09-11
410
Participants Needed
15
Research Sites
234 weeks
Total Duration
On this page
Sponsors
C
Catharina Ziekenhuis Eindhoven
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Predicting Response In Cervical Intraepithelial Neoplasia to Topical Imiquimod Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary cervical high-grade squamous intraepithelial lesions (cHSIL) such as CIN3 or CIN2 confirmed by biopsy
- For CIN2, expectative management discussion according to Dutch guidelines; patients choosing imiquimod can enroll
- Recurrent or residual cHSIL lesions after initial LLETZ treatment confirmed by biopsy
- Age 18 years or older
You will not qualify if you...
- Diagnosis of vaginal intraepithelial neoplasia (VAIN) such as vaginal HSIL
- PAP 4 cytology as indication for baseline colposcopy at study entry
- Diagnosis of adenocarcinoma in situ (AIS)
- Previous imiquimod therapy for cHSIL
- Previous cervical cancer
- Current malignant disease
- Immunodeficiency including HIV/AIDS or use of immunosuppressive medication
- Pregnancy
- Legal incapability
- Insufficient knowledge of the Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Amphia
Breda, Netherlands
Actively Recruiting
2
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Actively Recruiting
3
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
Actively Recruiting
4
Tergooi MC
Hilversum, Netherlands
Actively Recruiting
5
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
6
Leiden Universitair Medisch Centrum
Leiden, Netherlands
Not Yet Recruiting
7
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands
Actively Recruiting
8
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
9
Erasmus Medisch Centrum
Rotterdam, Netherlands
Actively Recruiting
10
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
Actively Recruiting
11
HagaZiekenhuis
The Hague, Netherlands
Actively Recruiting
12
Diakonessenhuis
Utrecht, Netherlands
Actively Recruiting
13
Máxima MC
Veldhoven, Netherlands
Actively Recruiting
14
VieCuri Medisch Centrum
Venlo, Netherlands
Actively Recruiting
15
Isala
Zwolle, Netherlands
Actively Recruiting
Research Team
C
Caroline Muntinga, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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