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Completed

NCT Number: NCT03509415

Reflectance Confocal Microscopy to Diagnose BCC

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.

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Key information

Conditions

Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Skin Care Network Barnet Ltd

London, EN5 4QS, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Patient suspected of having a primary basal cell carcinoma that is a candidate for surgical treatment.
  • Patient willing and able to give informed consent

Exclusion criteria

  • Recurrent or other higher-risk BCC
  • Patient with basal cell naevus syndrome
  • Patient treated with hedgehog inhibitor medication (vismodegib)
  • Patient not suitable for diagnostic biopsy
  • Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator
  • Patient with co-morbidities such as other skin disease

Treatment and study plan

In-vivo imaging

Diagnostic Test

Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).

Primary outcomes

  1. 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

Secondary outcomes

  1. intra- & inter-observer agreement for interpreting the RCM images

    Time frame: 6 months

    A measure of how consistently readers can diagnose from confocal images.

Sponsors and collaborators

Lead sponsor

Skin Care Network Ltd.

Industry

Registry information

Official study title

Reflectance Confocal Microscopy to Diagnose Basal Cell Carcinoma

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2018
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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