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An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.
Sponsor: University of Auckland, New Zealand
Summary
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.
Official title: A Multi-Centre Observational Study For The Collection Of A Raman Spectral Database Using The LumAssure Device In Adult Participants Undergoing Dermatological Assessment Of Skin Conditions
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
3000
Start Date
2024-12-13
Completion Date
2026-02-28
Last Updated
2024-10-28
Healthy Volunteers
Yes
Conditions
Locations (2)
Manukau Super clinic
Auckland, New Zealand
Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial
Auckland, New Zealand