Reflectance Confocal Microscopy to Diagnose BCC

April 15, 2024 updated by: Skin Care Network Ltd.

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EN5 4QS
        • Skin Care Network Barnet Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for BCC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 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
During exam (biopsy results typically available within one week).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intra- & inter-observer agreement for interpreting the RCM images
Time Frame: 6 months
A measure of how consistently readers can diagnose from confocal images.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skin Care Network Ltd.

Investigators

  • Principal Investigator: Howard Stevens, MA PhD, Skin Care Network Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

December 28, 2019

Study Completion (Actual)

December 28, 2019

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-MAV-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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