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Completed

NCT Number: NCT03508297

Reflectance Confocal Microscopy to Diagnose MM & LM

A reflectance confocal microscope is a machine which is able to examine the upper layers of the skin painlessly and without the need for taking a biopsy. We would like to examine the images taken by the confocal microscope to see if it can help more accurately identify lesions which are worrying rather than a benign mole. We are performing this study in patients in whom we have recommended excising a mole to exclude a cancer. If the results of the study show that the confocal microscope can help more accurately diagnose Melanomas then this would reduce the number of biopsies that are taken that turn out not to be cancerous (ie unnecessary biopsies).

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Key information

Conditions

Melanoma (Skin) Hutchinson's Melanotic Freckle Lentigo Maligna Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas 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 MM and LM.

Study Endpoints The hypothesis of this study is that the use of RCM is would reduce the NNE prior to definitive treatment by at least 30% from the current value of approximately 10.

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).

Setting and recruitment Patients will be recruited from the outpatient clinics of the Skin Care Network Barnet, and from the outpatient clinics of the Chase Farm and Barnet sites of Royal Free Hospital NHS Foundation Trust.

Participants The number of true negative lesions examined in this study will be 654. It is anticipated that this will result in a total of 661 lesions being recruited. 10% of participants are expected to have more than one lesion sampled.

The result of biopsy for each lesion will not be known until after the lesion has been included in the study. Therefore lesions will be added to the study until the required number of true negatives has been included.

Who can participate

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

Inclusion criteria

  • Age 18 years or older
  • Patient with a pigmented lesion recommended for excision because of suspicion of MM or LM.
  • Patient willing and able to give informed consent

Exclusion criteria

  • Recurrent MM or LM
  • Patient on immunosuppresants
  • Patient with significant co-morbidity or skin disease
  • Patient not suitable for diagnostic biopsy
  • Location of lesion unsuitable, inaccessible or impractical for scanning with RCM as determined by investigator

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. Number Needed to Excise

    Time frame: During exam (biopsy results typically available within one week).

    The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion

Secondary outcomes

  1. intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater

    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 Malignant Melanoma and Lentigo Maligna

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 25, 2018
Registry last updated
Nov 12, 2021

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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