Reflectance Confocal Microscopy to Diagnose BCC

Status Completed

Clinical Trial Summary

It is proposed to undertake a study to determine the diagnostic utility of using RCM for the diagnosis of Basal Cell Carcinoma (BCC) in a tertiary referral centre as outlined by the recent NICE report (Nov 2015). This will allow an assessment of the potential to avoid diagnostic biopsy within the treatment pathway.

Clinical Trial Description

Study Design This is an observational, non-randomised, non-controlled, prospective cohort study to look at the efficacy of in vivo RCM as a diagnostic tool in the diagnosis of BCC. Study Hypothesis The hypothesis of this study is that the use of RCM is would enable a reduction in the number of diagnostic biopsies taken before definitive treatment of BCC by at least 50%. The secondary hypothesis is that the intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater (indicating good agreement). Patients will be recruited from the outpatient clinic of Skin Care Network London. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03509415
Study type	Observational
Source	Skin Care Network Ltd.
Contact
Status	Completed
Phase
Start date	March 15, 2017
Completion date	December 28, 2019

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