This is an observational study in adult males and females utilising skin condition measurements using the LumAssure Raman device. Data will be used to determine accuracy under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign and cancerous skin conditions. The measurements will provide data which will be used to establish spectral parameters for different skin conditions. Measurements will be benchmarked against diagnoses from medical specialists, and when available confirmed with histological data.
The main question it aims to answer is :
What is the accuracy, in terms of the area under the ROC curve (AUCROC) of the LumAssure device for differentiating between benign skin conditions and skin cancers in adult males and females? Participants include males and females aged ≥18 years who are undergoing assessment of a skin condition (a lesion or rash) by a dermatologist, general practitioner, or plastic surgeon. Participants' attending the clinics will have their skin conditions examined by a clinician. The LumAssure device will then be used to measure Raman spectra of skin conditions and marked by the clinician. The Raman measurements will be benchmarked against skin condition assessment and, where available, diagnosis by a dermatologist, general practitioner, or a plastic surgeon, and for those lesions undergoing biopsy, confirmed with histology data.
Able to provide informed consent
Male or female aged 18 years or over.
Willing to undergo a LumAssure device measurement on at least 1 skin condition
(For Standard of Care patients): are undergoing a skin examination and/or tissue excision by a qualified specialist
Tattoo on the skin condition to be measured
Skin conditions on or directly around the eye area
The first group of participants (healthy volunteers), will be those who can attend a free skin check at the Clinical Research Centre at the University of Auckland medical school. The second group of participants (patients referred to/attending a clinic for a skin assessment) will be those attending one of five clinics in the city of Auckland and towns of Dargaville and Hokianga, in New Zealand.
Case-control
Cross-sectional
Not listed
Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
The primary endpoint of the study will be the area under the ROC curve (AUCROC) of the LumAssure Raman device measurements for the differentiation between benign skin conditions and skin cancers. The primary aim is to collect sufficient LumAssure Raman device measurements of skin conditions to develop an algorithm which can help detect diagnosed skin conditions and malignancies determined via histological analysis of biopsied samples.
Number of participants with adverse events and descriptions of adverse events
Secondary endpoints: The number of participants with adverse events will be recorded, and the types of adverse events will be describes and categorized according to severity (high, medium or low risk).
Number and type of device inadequacies
Recording of the number and types of issues encountered with device function or performance, and categorized according to low, medium or high risk.
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University of Auckland, New Zealand
Lead sponsor
Auckland UniServices Ltd.
Collaborator
Counties Manukau Health
Collaborator
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