RCM-1 Study
Research type
Research Study
Full title
Reflectance confocal microscopy to diagnose basal cell carcinoma: RCM-1 Study
IRAS ID
206698
Contact name
Jennifer J Garioch
Contact email
Sponsor organisation
Norfolk and Norwich University Hospital
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Research Summary
Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. At the Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) we see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a biopsy to confirm their diagnosis before being listed for surgical excision. Booking patients for diagnostic biopsies and waiting for results leads to significant delays in patients being booked for surgical excision. In vivo reflectance confocal microscopy (RCM) involves using a machine which can examine the upper layers of the skin non invasively.
In clinically suspicious lesions, we will use RCM prior to biopsy with the aim of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine the feasibility and utility of using RCM for the diagnosis of BCC in the NHS clinic setting, thereby shortening the patient pathway and effectively using limited public resources. If our study shows that RCM can accurately diagnose BCC in these patients then this would prevent the need for biopsy as a routine in these patients.Summary of Results
We undertook a feasibility study to determine if reflectance confocal microscopy could be used to accurately diagnose a type of skin cancer called a basal cell carcinoma. Confocal microscopy is a novel non invasive technique which can examine the upper layers of the skin without the need for a biopsy.We designed a non randomised, single arm, prospective cohort study for adult patients with a clinical diagnosis of basal cell carcinoma of the head and neck region, being considered for Mohs surgery. Patients had imaging of their lesions with the confocal microscope followed by a biopsy for conventional histology. The images were assessed by two dermatologists who had been trained in reading images produced by the confocal microscope. The assessing dermatologists were blinded to the patient's history and histology results.
283 datasets were included in the study. The incidence of BCC was 76.3% 0216/283) on histology. The accuracy of the blinded assessors was 83.7% and 78.1%; however, the diagnostic accuracy improved to 97.3% with high quality images taken on flat surfaces such as the forehead and cheek.
This study has shown that confocal microscopy confirmed the diagnosis of BCC in over 97% of patients with head and neck lesions clinically suspicious for basal cell carcinoma being considered for Mohs surgery. This means that a large proportion of patients could potentially avoid a biopsy prior to definitive treatment thus speeding up their pathway.
REC name
West of Scotland REC 4
REC reference
16/WS/0122
Date of REC Opinion
17 Jun 2016
REC opinion
Favourable Opinion