RCM to Diagnose BCC - Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Observational

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.
    

Intervention name(s): Reflectance Confocal Microscopy
Intervention type(s): Diagnostic Test
Intervention description(s): In-vivo microscope
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        See Above
      
Keywords: confocal; basal; carcinoma