NCT03509415

Reflectance Confocal Microscopy to Diagnose BCC

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 324 (actual)
• Sponsor: Skin Care Network Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	In-vivo imaging	Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Timeline

• Start date: 2017-03-15
• Primary completion: 2019-12-28
• Completion: 2019-12-28
• First posted: 2018-04-26
• Last updated: 2024-04-16

Locations

1 site across 1 country: United Kingdom