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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06252857
Other study ID # 2023-0356
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 22, 2024
Est. completion date April 2026

Study information

Verified date April 2024
Source Maastricht University Medical Center
Contact Myrthe MG Moermans, MD
Phone +31433877295
Email myrthe.moermans@mumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Basal cell carcinoma (BCC) is the most prevalent form of cancer among the Caucasian population. There are several subtypes of BCC with different clinical characteristics and treatment strategies. Superficial and nodular BCCs are low-risk BCC subtypes. The diagnosis and subtype of BCC can be confirmed by means of punch biopsy, but non-invasive diagnosis by means of Optical Coherence Tomography (OCT) is proven to be a non-inferior alternative diagnostic instrument. Besides, non-invasive topical treatment is recommended as valuable treatment alternative to surgical excision for low-risk BCC. Since non-invasive diagnosis and treatment for low-risk BCC is being implemented into daily practice, we want to evaluate the real-world effectiveness of different invasive and non-invasive diagnostic and treatment strategies in the management of low-risk BCC. This real-world evidence will enhance our understanding of these management strategies for low-risk BCC in daily practice.


Recruitment information / eligibility

Status Recruiting
Enrollment 142
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients =18 years old - Diagnosis of low-risk BCC based on CDE with OCT confirmation or with histopathological verification in case OCT diagnosis is doubtful. - Tumors meeting the criteria for low-risk BCC - Patient is able to understand the instruction regarding the study participation and application of IMQ treatment Exclusion Criteria: - Tumor location in the H-zone of the face or hairy scalp, anogenital area - Diagnosis of recurrent BCC or previous skin cancer within 2cm of the treatment area - Strong suspicion/diagnosis of high-risk BCC subtype or other skin condition on OCT or punch biopsy - Women who are pregnant or breastfeeding - Previous allergy or intolerance to IMQ - No concurrent use any other systemic chemopreventive or immunosuppressive medication during the treatment period, 30 days before start and 3 months after the end of treatment - Limited understanding of the Dutch language and not being able to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Imiquimod Topical
Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision.

Locations

Country Name City State
Netherlands Maastricht UMC+ Maastricht Limburg

Sponsors (1)

Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of imiquimod versus surgical excision Treatment success, expressed as the proportion of tumor free patients 1 year post-treatment
Secondary Adverse effects Incidence and severity of adverse effects During imiquimod treatment, reported by the patient
Secondary Mean treatment compliance for patients in the imiquimod group In percentages During treatment, reported by the patient in a treatment checklist
Secondary Cosmetic outcome Patient-reported satisfaction with cosmetic result of treatment area, expressed as mean score on the DASS questionnaire 1 year post-treatment
Secondary Patient treatment satisfaction Patient-reported satisfaction with treatment, expressed as the proportion of patients reporting to be satisfied with their treatment on a 4-point Likert-scale. 1 year post-treatment
Secondary Cost-effectiveness analysis Cost-effectiveness will be analysed from a health-care perspective: pre-, during and post-treatment costs will be recorded and analysed and compared in both treatment groups using a cost-effectiveness analysis (CEA) 1 year post-treatment
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