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

NCT06252857 | Recruiting FDA Drug

• 1 other identifier: 2023-0356
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Keywords

imiquimod; surgical excision

Outcome Measures

Primary Outcomes (1)

• Effectiveness of imiquimod versus surgical excision

  Treatment success, expressed as the proportion of tumor free patients

  1 year post-treatment

Secondary Outcomes (5)

• Adverse effects

  During imiquimod treatment, reported by the patient

• Mean treatment compliance for patients in the imiquimod group

  During treatment, reported by the patient in a treatment checklist

• Cosmetic outcome

  1 year post-treatment

• Patient treatment satisfaction

  1 year post-treatment

• Cost-effectiveness analysis

  1 year post-treatment

Interventions

Imiquimod Topical DRUG

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

Also known as: Surgical Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Myrthe MG Moermans, MD

CONTACT

+31433877295; myrthe.moermans@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 12, 2024
• Study Start: April 22, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

NL (1)