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

Basal Cell Carcinoma Clinical Trial

— REDT-BCC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252857
• Other study ID #: 2023-0356
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

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