Reflectance Confocal Microscopy to Diagnose BCC

Completed

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT03509415
• Lead Sponsor: Skin Care Network Ltd.

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.

Study Timeline

• Study Start: 2017-03-15
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Primary Completion: 2019-12-28
• Study Completion: 2019-12-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
intra- & inter-observer agreement for interpreting the RCM images	6 months	A measure of how consistently readers can diagnose from confocal images.

Trial Locations

Locations (1)

Skin Care Network Barnet Ltd; 🇬🇧 London, United Kingdom