An observational study in Melanoma (Skin) and Lentigo Maligna, sponsored by Skin Care Network Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-12.
Sponsored by Skin Care Network Ltd. · Observational
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).
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.
Patients presenting at a skin cancer clinic with a lesion that is clinically suspicious for LM or MM.
Exclusion Criteria:
Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
Number Needed to Excise
The number of suspicious lesions (defined by conventional histology) biopsied to find one cancerous lesion
Time frame: During exam (biopsy results typically available within one week).
intra- & inter-observer agreement for interpreting the RCM images will have kappa scores 0.6 or greater
A measure of how consistently readers can diagnose from confocal images.
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Skin Care Network Ltd.