An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.

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.

NCT Number	NCT06661577
Lead Sponsor	University of Auckland, New Zealand Collaborators: Auckland UniServices Ltd., Counties Manukau Health
Conditions	Skin Cancers - Basal Cell Carcinoma, Skin Cancers - Squamous Cell Carcinoma, Melanoma of Skin, Inflammatory Dermatoses, Acral Melanoma, Benign Skin Nevus, Benign Skin Tumor
Enrollment	3,000 participants
Start Date	2024-12-13
Primary Completion	2025-12-18 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2024-10-28