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

NCT06661577 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-10-28

No results posted yet for this study

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.

Conditions

  • Skin Cancers - Basal Cell Carcinoma
  • Skin Cancers - Squamous Cell Carcinoma
  • Melanoma of Skin
  • Inflammatory Dermatoses
  • Acral Melanoma
  • Benign Skin Nevus
  • Benign Skin Tumor

Sponsors & Collaborators

  • Auckland UniServices Ltd.

    collaborator INDUSTRY

  • Counties Manukau Health

    collaborator OTHER

  • University of Auckland, New Zealand

    lead OTHER

Principal Investigators

  • Michel K Nieuwoudt, PhD · The University of Auckland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2025-12-18
Completion
2026-02-28

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661577 on ClinicalTrials.gov