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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331874
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date November 1, 2017
First Posted Date November 6, 2017
Last Update Posted Date October 8, 2020
Actual Study Start Date March 3, 2017
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 1, 2017)
Inter- & intra-observer agreement in assessing RCM images [ Time Frame: 18 months ]
Inter- & intra-observer agreement in assessing RCM images
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title RCM to Diagnose BCC - Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
Official Title Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
Brief Summary

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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population See Above
Condition Basal Cell Carcinoma
Intervention Diagnostic Test: Reflectance Confocal Microscopy
In-vivo microscope
Study Groups/Cohorts Basal Cell Carcinoma
Diagnosis of Basal Cell Carcinoma by Reflectance confocal microscopy
Intervention: Diagnostic Test: Reflectance Confocal Microscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 7, 2020)
352
Original Estimated Enrollment
 (submitted: November 1, 2017)
345
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date November 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

-

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03331874
Other Study ID Numbers 206698(59-03-16)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust
Study Sponsor Julie Dawson
Collaborators Not Provided
Investigators
Principal Investigator: Jennifer Garioch, Dr Consultant Oncologist
PRS Account Norfolk and Norwich University Hospitals NHS Foundation Trust
Verification Date October 2020