Real-world Evaluation of Diagnostic and Treatment Strategies in Low-Risk Basal Cell Carcinoma (REDT-BCC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Basal Cell Carcinoma
• Intervention / Treatment: Drug: Imiquimod Topical

• Study Type: Observational
• Enrollment (Estimated): 142

Contacts and Locations

• Study Contact: Name: Myrthe MG Moermans, MD; Phone Number: +31433877295; Email: myrthe.moermans@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Recruiting
      • Maastricht UMC+
      • Contact: Myrthe MG Moermans, MD; Phone Number: +31433877295; Email: myrthe.moermans@mumc.nl
      • Principal Investigator: Klara Mosterd, Prof.
      • Sub-Investigator: Myrthe Moermans, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients visiting the outpatient department of MUMC+ with a clinical suspicion for low-risk BCC, who have a final diagnosis of low-risk BCC confirmed by OCT, or by punch biopsy in case uncertainty about diagnosis remains after OCT. Patients will be treated in accordance with standard care: either SE or IMQ. The choice for treatment is based on shared decision making.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of imiquimod versus surgical excision	Treatment success, expressed as the proportion of tumor free patients	1 year post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	Incidence and severity of adverse effects	During imiquimod treatment, reported by the patient
Mean treatment compliance for patients in the imiquimod group	In percentages	During treatment, reported by the patient in a treatment checklist
Cosmetic outcome	Patient-reported satisfaction with cosmetic result of treatment area, expressed as mean score on the DASS questionnaire	1 year post-treatment
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
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: imiquimod; surgical excision
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Adjuvants, Immunologic; Interferon Inducers; Toll-Like Receptor Agonists; Immunomodulating Agents; Imiquimod
• Other Study ID Numbers: 2023-0356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes