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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Auckland, New Zealand

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Tattoo on the skin condition to be measured

Skin conditions on or directly around the eye area

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

3,000 Participants
are grouped into 2 trial groups

Sponsors and collaborators

University of Auckland, New Zealand

Lead sponsor

Auckland UniServices Ltd.

Collaborator

Counties Manukau Health

Collaborator