Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma

Recruiting

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT06252857
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-12
• Status Verified: 2024-04
• Study Start: 2024-04-22
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness of imiquimod versus surgical excision	1 year post-treatment	Treatment success, expressed as the proportion of tumor free patients

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness analysis	1 year post-treatment	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)
Adverse effects	During imiquimod treatment, reported by the patient	Incidence and severity of adverse effects
Mean treatment compliance for patients in the imiquimod group	During treatment, reported by the patient in a treatment checklist	In percentages
Cosmetic outcome	1 year post-treatment	Patient-reported satisfaction with cosmetic result of treatment area, expressed as mean score on the DASS questionnaire
Patient treatment satisfaction	1 year post-treatment	Patient-reported satisfaction with treatment, expressed as the proportion of patients reporting to be satisfied with their treatment on a 4-point Likert-scale.

Trial Locations

Locations (1)

Maastricht UMC+; 🇳🇱 Maastricht, Limburg, Netherlands