Reflectance Confocal Microscopy to Diagnose BCC

Skin Care Network Ltd.324 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

324

Conditions

Basal Cell Carcinoma

Interventions

In-vivo imagingDIAGNOSTIC_TEST

Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 years or older 2. Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment. 3. Patient willing and able to give informed consent Exclusion Criteria: 1. Recurrent or other higher-risk BCC 2. Patient with basal cell naevus syndrome 3. Patient treated with hedgehog inhibitor medication (vismodegib) 4. Patient not suitable for diagnostic biopsy 5. Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator 6. Patient with co-morbidities such as other skin disease

Locations (1)

Skin Care Network Barnet Ltd

London, United Kingdom

Outcomes

Primary Outcomes

Sensitivity and Specificity

Specificity \& Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology

Time frame: During exam (biopsy results typically available within one week).

Secondary Outcomes

intra- & inter-observer agreement for interpreting the RCM images

A measure of how consistently readers can diagnose from confocal images.

Time frame: 6 months

Data from ClinicalTrials.gov

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