Reflectance Confocal Microscopy to Diagnose BCC
1 other identifier
observational
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2019
CompletedApril 16, 2024
April 1, 2024
2.8 years
April 16, 2018
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (1)
intra- & inter-observer agreement for interpreting the RCM images
6 months
Interventions
Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
Eligibility Criteria
Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for BCC
You may qualify if:
- Age 18 years or older
- Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
- Patient willing and able to give informed consent
You may not qualify if:
- Recurrent or other higher-risk BCC
- Patient with basal cell naevus syndrome
- Patient treated with hedgehog inhibitor medication (vismodegib)
- Patient not suitable for diagnostic biopsy
- Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
- Patient with co-morbidities such as other skin disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Skin Care Network Barnet Ltd
London, EN5 4QS, United Kingdom
Related Publications (1)
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.
PMID: 39259284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Howard Stevens, MA PhD
Skin Care Network Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
April 26, 2018
Study Start
March 15, 2017
Primary Completion
December 28, 2019
Study Completion
December 28, 2019
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share