RCM to Diagnose BCC - Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma (RCM-1)

October 7, 2020 updated by: Julie Dawson

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Basal cell carcinoma (BCC) is the commonest non melanoma skin cancer in the UK and its incidence is rising. The Norfolk and Norwich University Hospital Foundation Trust (NNUHFT) see and excise approximately 3,000 new cases of BCC each year. Many of these patients have a biopsy to confirm their diagnosis before being listed for surgical excision. In vivo reflectance confocal microscopy (RCM) involves using a machine which can examine the upper layers of the skin non invasively.

In clinically suspicious lesions, the Investigators will use RCM prior to biopsy with the aim of demonstrating that RCM can accurately diagnose BCC. The aim of this study is to determine the feasibility and utility of using RCM for the diagnosis of BCC in the NHS setting, thereby shortening the patient pathway and effectively using limited public resources. If the Investigators' study shows that RCM can accurately diagnose BCC in these patients then this would prevent the need for biopsy as a routine in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited from the outpatient clinics of the Departments of Dermatology and Plastic Surgery at the Norfolk and Norwich University Hospital Foundation Trust. These will be patients who have been assessed in clinic by a consultant dermatologist or consultant plastic surgeon. They will be suspected of having a BCC on the head and neck region. Clinical and dermoscopic (a dermatoscope is a hand held microscope) images will be taken by the Medical Illustration at NNUHFT as part of their routine standard of care. Patients will be invited to participate in the trial and provided with a patient information leaflet. They will be given sufficient time to review the information sheet and ask questions. Patients will be consented to having reflectance confocal microscopy performed of the target lesion before undergoing biopsy for histology. These patients would be having photographs, including dermoscopic images, and a biopsy as part of their standard of care prior to their final treatment being determined - the only additional intervention is examination with the confocal microscope.

The images taken of the tumour by the reflectance confocal microscope will be anonymised. These images will then be examined by a different in house dermatologist who has undergone training in examining confocal images. The images will also be sent to a dermatologist in Modena, Italy who is experienced in interpreting confocal microscopic images - both of these dermatologists will be blinded as to the patient's history and the results of the punch biopsy.

The biopsies will undergo routine processing in our histopathology laboratory as normal and will be analysed by a pathologist who will be unaware of the findings on confocal microscopy.

The patients will undergo one additional intervention over-and-above their standard investigation and treatment pathway. The treatment pathway for the patients will not be lengthened or shortened by their participation.

Study Type

Observational

Enrollment (Actual)

352

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
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospitals NHS Foundation Trust

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 to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

See Above

Description

Inclusion Criteria: Patients 18 years or older with a suspected diagnosis of BCC of the head and neck region.

-

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Basal Cell Carcinoma
Diagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy
Diagnostic test: Reflectance Confocal Microscopy
In-vivo microscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology
Time Frame: 18 months
Specificity & Sensitivity of RCM in diagnosing BCC compared to standard histology
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter- & intra-observer agreement in assessing RCM images
Time Frame: 18 months
Inter- & intra-observer agreement in assessing RCM images
18 months

Collaborators and Investigators

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

Sponsor

Julie Dawson

Investigators

  • Principal Investigator: Jennifer Garioch, Dr, Consultant Oncologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 3, 2017

Primary Completion (Actual)

November 27, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206698(59-03-16)

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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