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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-vivo imaging | Diagnostic Test | Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Specificity & Sensitivity of RCM in diagnosing Basal Cell Carcinoma in non-pigmented lesions compared to standard histology | During exam (biopsy results typically available within one week). |
| Measure | Description | Time Frame |
|---|---|---|
| intra- & inter-observer agreement for interpreting the RCM images | A measure of how consistently readers can diagnose from confocal images. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for BCC
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| Name | Affiliation | Role |
|---|---|---|
| Howard Stevens, MA PhD | Skin Care Network Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care Network Barnet Ltd | London | EN5 4QS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39259284 | Derived | Stevens HP, Pampena R, Farnetani F, Pellacani G, Angus C, El-Jabbour JN. Reflectance confocal microscopy in diagnosing basal cell carcinoma in the UK: a prospective observational single-centre trial. Br J Dermatol. 2025 Jan 24;192(2):206-214. doi: 10.1093/bjd/ljae356. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Apr 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069416 | Intravital Microscopy |
| ID | Term |
|---|---|
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D018295 |
| Neoplasms, Basal Cell |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008919 |
| Investigative Techniques |