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Spots Global Cancer Trial Database for Reflectance Confocal Microscopy to Diagnose BCC

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Trial Identification

Brief Title: Reflectance Confocal Microscopy to Diagnose BCC

Official Title: Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Study ID: NCT03509415

Interventions

In-vivo imaging

Study Description

Brief 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.

Detailed 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Skin Care Network Barnet Ltd, London, , United Kingdom

Contact Details

Name: Howard Stevens, MA PhD

Affiliation: Skin Care Network Ltd.

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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