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

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 28, 2024 (before its estimated December 18, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06661577
Lead Sponsor University of Auckland, New Zealand
Collaborators: Auckland UniServices Ltd., Counties Manukau Health
Conditions
(from sponsor)
Skin Cancers - Basal Cell Carcinoma, Skin Cancers - Squamous Cell Carcinoma, Melanoma of Skin, Inflammatory Dermatoses, Acral Melanoma, Benign Skin Nevus, Benign Skin Tumor
Related terms Basal Cell Carcinoma, Melanoma, Nevus, Skin Neoplasms
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov