title: Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial.
abstract: BACKGROUND
  Skin cancer, including basal cell carcinoma (BCC), has become a major health care problem. The limitations of a punch biopsy (at present the gold standard) as diagnostic method together with the increasing incidence of skin cancer point out the need for more accurate, cost-effective, and patient friendly diagnostic tools. In vivo reflectance confocal microscopy (RCM) is a noninvasive imaging technique that has great potential for skin cancer diagnosis.
  
  
  OBJECTIVE
  To investigate whether in vivo RCM can correctly identify the subtype of BCC and to determine the cost-effectiveness of RCM compared with punch biopsy (usual care).
  
  
  METHODS
  Randomized controlled multicenter trial.
  
  
  METHODS
  On the basis of 80% power and an alpha of 0.05, 329 patients with lesions clinically suspicious for BCC will be included in this study. Patients will be randomized for RCM or for a punch biopsy (usual care). When a BCC is diagnosed, surgical excision will follow and a follow-up visit will be planned 3 months later. Several questionnaires will be filled in (EQ-5D, EQ-5D VAS, iMTA PCQ, and TSQM-9). We will perform statistical analysis, cost-effectiveness, and patient outcome analysis after data collection.
  
  
  RESULTS
  This research started in January 2016 and is ethically approved. We expect to finish this study at the end of 2018.
  
  
  CONCLUSIONS
  In this study, we will investigate whether RCM is at least as good in identifying BCC subtypes as conventional pathological investigation of skin biopsies. Anticipating that RCM is found to be a cost-effective alternative, it saves on direct medical consumption like labor of the pathologist and other medical personnel as well as materials related to treatment failure with at least equal effectiveness.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02623101; https://clinicaltrials.gov/ct2/show/NCT02623101 (Archived by WebCite at http://www.webcitation.org/6id54WQa2).
authors.affiliation: Radboud University Medical Center, Department of Dermatology, Nijmegen, Netherlands. malou.peppelman@radboudumc.nl.
authors.forename: Malou
authors.identifier: http://orcid.org/0000-0001-8636-2974
authors.initials: M
authors.lastname: Peppelman
authors.forename: Kim P
authors.identifier: http://orcid.org/0000-0002-2206-537X
authors.initials: KP
authors.lastname: Nguyen
authors.forename: Hans A C
authors.identifier: http://orcid.org/0000-0002-5055-7275
authors.initials: HA
authors.lastname: Alkemade
authors.forename: Birgitte
authors.identifier: http://orcid.org/0000-0002-6972-0132
authors.initials: B
authors.lastname: Maessen-Visch
authors.forename: Jan C M
authors.identifier: http://orcid.org/0000-0002-0496-4304
authors.initials: JC
authors.lastname: Hendriks
authors.forename: Piet E J
authors.identifier: http://orcid.org/0000-0002-6955-8817
authors.initials: PE
authors.lastname: van Erp
authors.forename: Eddy M M
authors.identifier: http://orcid.org/0000-0002-4773-6176
authors.initials: EM
authors.lastname: Adang
authors.forename: Marie-Jeanne P
authors.identifier: http://orcid.org/0000-0003-3740-3711
authors.initials: MJ
authors.lastname: Gerritsen
keywords: basal cell carcinoma; cost effectiveness; diagnosis; reflectance confocal microscopy