Basal Cell Carcinoma
Conditions
Keywords
Confocal, RCM, Imaging, Skin cancer
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.
Interventions
DIAGNOSTIC_TESTIn-vivo imaging
Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
Sponsors
Skin Care Network Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity | During exam (biopsy results typically available within one week). | Specificity & Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intra- & inter-observer agreement for interpreting the RCM images | 6 months | A measure of how consistently readers can diagnose from confocal images. |
Countries
United Kingdom
Outcome results
None listed