NCT06252857

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

Real-world Evaluation of (Non-invasive) Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma: a Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 142 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Imiquimod Topical	Topical application of imiquimod (once daily, 5 days a week, during 6 weeks) versus surgical excision.

Timeline

• Start date: 2024-04-22
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-02-12
• Last updated: 2024-05-01

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study