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

NCT ID: NCT06661577

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-13
• Study Completion Date: 2026-02-28

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.

Detailed Description

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Auckland UniServices Ltd.

INDUSTRY

Sponsor Role: collaborator

Counties Manukau Health

OTHER

Sponsor Role: collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role: lead

Responsible Party

Michel Nieuwoudt

Senior Research Fellow, Principal Investigator, The School of Chemical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel K Nieuwoudt, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Auckland

Locations

Manukau Super clinic

Auckland, , New Zealand

Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial

Auckland, , New Zealand

Countries

New Zealand

Central Contacts

Michel K Nieuwoudt, PhD

Role: CONTACT

m.nieuwoudt@auckland.ac.nz

+64210378601

Paul Jarrett, MBBS,DCCH,MD

Role: CONTACT

Paul.Jarrett@middlemore.co.nz

Facility Contacts

Paul Jarrett, MBBS, DCCH, DGM,MD, FRCP,FRACP

Role: primary

Paul.Jarrett@middlemore.co.nz

+6421848109

Michelle B Locke, BHB, MBChB, MD,FRACS(Plastics)

Role: primary

Michelle.Locke@middlemore.co.nz

+6421963533

Paul Jarrett, MBBS,DCCH,MD,DGM,MD,FRCP,FRACP

Role: backup

Paul.Jarrett@middlemore.co.nz

Other Identifiers

HDEC 21297

Identifier Type: OTHER

Identifier Source: secondary_id

HDEC21297

Identifier Type: -

Identifier Source: org_study_id