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

NCT06661577 | Not Yet Recruiting DMC

• 2 other identifiers: HDEC21297HDEC 21297
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

skin cancers; melanoma; diagnostic device

Outcome Measures

Primary Outcomes (1)

• Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers

  The primary endpoint of the study will be the area under the ROC curve (AUCROC) of the LumAssure Raman device measurements for the differentiation between benign skin conditions and skin cancers. The primary aim is to collect sufficient LumAssure Raman device measurements of skin conditions to develop an algorithm which can help detect diagnosed skin conditions and malignancies determined via histological analysis of biopsied samples.

  Day 1, baseline, 12 months

Secondary Outcomes (1)

• Number of participants with adverse events and descriptions of adverse events

  Day 1, baseline, 12 months

Other Outcomes (1)

• Number and type of device inadequacies

  Day1, baseline, 12 months

Study Arms (2)

Healthy volunteers

Male and female healthy volunteers, aged 18 years or over, attending a study specific skin check appointment, without a diagnosis or histology of malignancies.

SOC Patients

Participants attending a standard of care medical appointment at a skin clinic, a plastic surgery or a general practitioner for assessment, diagnosis and/or potential excision of a skin condition, With confirmatory medical practitioner diagnosis, and where appropriate confirmatory histological analysis of excised tissues

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The first group of participants (healthy volunteers), will be those who can attend a free skin check at the Clinical Research Centre at the University of Auckland medical school. The second group of participants (patients referred to/attending a clinic for a skin assessment) will be those attending one of five clinics in the city of Auckland and towns of Dargaville and Hokianga, in New Zealand.

You may qualify if:

• 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
• (For Healthy volunteers): are attending a skin check at a study clinic

You may not qualify if:

• Tattoo on the skin condition to be measured
• Skin conditions on or directly around the eye area

Sponsors & Collaborators

• University of Auckland, New Zealand: lead
• Auckland UniServices Ltd.: collaborator
• Counties Manukau Health: collaborator

Study Sites (2)

Manukau Super clinic

Auckland, 0604, New Zealand

Location

Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial

Auckland, 1140, New Zealand

Location

MeSH Terms

Conditions

Carcinoma, Basal Cell; Melanoma; Nevus; Skin Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michel K Nieuwoudt, PhD

  The University of Auckland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel K Nieuwoudt, PhD

CONTACT

+64210378601; m.nieuwoudt@auckland.ac.nz

Paul Jarrett, MBBS,DCCH,MD

CONTACT

Paul.Jarrett@middlemore.co.nz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow, Principal Investigator, The School of Chemical Sciences

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: December 13, 2024
• Primary Completion: December 18, 2025
• Study Completion: February 28, 2026
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of the observational study
• Access Criteria: Report will be put into a web repository

Locations

NZ (2)