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NCT Number: NCT06661577

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.

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Key information

Conditions

Skin Cancers - Basal Cell Carcinoma Acral Melanoma Benign Skin Nevus Benign Skin Tumor Carcinoma Carcinoma, Basal Cell Inflammatory Dermatoses Melanoma Melanoma of Skin Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Skin Cancers - Squamous Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manukau Super clinic, Auckland, New Zealand

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About this study

For this observational study, Raman spectra will be measured in the clinic using the LumAssure device, on patients attending standard of care medical clinics (SOC participants) for skin assessments and/or biopsies, and on healthy volunteers attending a clinical research centre (HV participants). The LumAssure device was developed and utilised in a previous proof of concept study (https://doi.org/10.1016/j.xjidi.2023.100238). Development of a robust classification algorithm capable of distinguishing between malignant vs benign skin conditions requires the collection of clinical measurements from a large and diverse participant population with varied skin Fitzpatrick types.

Participants will be recruited via advertising. All participants must provide informed consent prior to study participation and data collection. SOC participants lesions of interest will be identified for LumAssure measurement by their medical specialist during their clinical visit.

Participant data will be de-identified, utilizing a unique study number, and entered directly into an electronic data capture system.

The study will be conducted in accordance with the protocol and applicable regulatory requirements. Participant rights and safety, and study data integrity will be monitored by an independent contract research organization in accordance with the protocol and established procedures.

Approximately 1,600 - 3,000 skin conditions assessment data point cases required from an estimated 400-750 participants (with an estimated 1-4 lesions per participant) will be collected for this study. The participant sample size has been determined by an independent biostatistician. The Protocol established criteria for data handling, management and analysis in order to achieve the primary and secondary objectives.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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

    Time frame: Day 1, baseline, 12 months

    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.

Secondary outcomes

  1. Number of participants with adverse events and descriptions of adverse events

    Time frame: Day 1, baseline, 12 months

    Secondary endpoints:

    The number of participants with adverse events will be recorded, and the types of adverse events will be describes and categorized according to severity (high, medium or low risk).

Other outcomes

  1. Number and type of device inadequacies

    Time frame: Day1, baseline, 12 months

    Recording of the number and types of issues encountered with device function or performance, and categorized according to low, medium or high risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Michel K Nieuwoudt, PhD

CONTACT

[email protected]

+64210378601

Paul Jarrett, MBBS,DCCH,MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Auckland UniServices Ltd.
  • Counties Manukau Health

Registry information

Official study title

A Multi-Centre Observational Study For The Collection Of A Raman Spectral Database Using The LumAssure Device In Adult Participants Undergoing Dermatological Assessment Of Skin Conditions

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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