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

Last updated: April 30, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Warts

Cancer/tumors

Treatment

Imiquimod Topical

Clinical Study ID

NCT06252857
2023-0356
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥18 years old
  • Diagnosis of low-risk BCC based on CDE with OCT confirmation or with histopathologicalverification 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 andapplication of IMQ treatment

Exclusion

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 orpunch biopsy
  • Women who are pregnant or breastfeeding
  • Previous allergy or intolerance to IMQ
  • No concurrent use any other systemic chemopreventive or immunosuppressive medicationduring the treatment period, 30 days before start and 3 months after the end oftreatment
  • Limited understanding of the Dutch language and not being able to give informedconsent

Study Design

Total Participants: 142
Treatment Group(s): 1
Primary Treatment: Imiquimod Topical
Phase:
Study Start date:
April 22, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Maastricht UMC+

    Maastricht, Limburg 6229 HX
    Netherlands

    Active - Recruiting

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