NCT02623101

Reflectance Confocal Microscopy in Basal Cell Carcinoma

Completed NA Last updated 20 September 2019

What this trial tests

NA trial testing Reflectance confocal microscopy in Carcinoma, Basal Cell in 288 participants. Completed in 31 May 2019.

Timeline

1 December 2015

Primary endpoint
31 May 2019

31 May 2019

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	288
Start date	1 December 2015
Primary completion	31 May 2019
Estimated completion	31 May 2019
Sites	3 locations across Netherlands

Drugs / interventions tested

• Reflectance confocal microscopy
• Punch biopsy
• Surgical excision

Conditions studied

• Carcinoma, Basal Cell — all drugs for Carcinoma, Basal Cell →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Carcinoma, Basal Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biopsy outperforms reflectance confocal microscopy in diagnosing and subtyping basal cell carcinoma: results and experiences from a randomized controlled multicentre trial.
   Woliner-van der Weg W, Peppelman M, Elshot YS, Visch MB, et al · · 2021 · cited 19× · PMID 32628771 · DOI 10.1111/bjd.19381
2. Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial.
   Peppelman M, Nguyen KP, Alkemade HA, Maessen-Visch B, et al · · 2016 · cited 6× · PMID 27363577 · DOI 10.2196/resprot.5757