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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

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.


Condition or disease Intervention/treatment
Basal Cell Carcinoma Diagnostic Test: Reflectance Confocal Microscopy

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.

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Study Type : Observational
Actual Enrollment : 352 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
Actual Study Start Date : March 3, 2017
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Inter- & intra-observer agreement in assessing RCM images [ Time Frame: 18 months ]
    Inter- & intra-observer agreement in assessing RCM images



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
See Above
Criteria

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

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Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331874


Locations
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United Kingdom
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Sponsors and Collaborators
Julie Dawson
Investigators
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Principal Investigator: Jennifer Garioch, Dr Consultant Oncologist
Publications:

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Responsible Party: Julie Dawson, Research Services Manager, Norfolk and Norwich University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03331874    
Other Study ID Numbers: 206698(59-03-16)
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Dawson, Norfolk and Norwich University Hospitals NHS Foundation Trust:
confocal
basal
carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell