Clinical trial NCT06661577: An Observational Study Using The LumAssure Device In Participants Undergoing Assessment Of Skin Conditions.
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Auckland UniServices Ltd.
name: Counties Manukau Health
First posted: 2024-10-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers
timeFrame: Day 1, baseline, 12 months
Secondary outcomes:
measure: Number of participants with adverse events and descriptions of adverse events
timeFrame: Day 1, baseline, 12 months
Other outcomes:
measure: Number and type of device inadequacies
timeFrame: Day1, baseline, 12 months
Locations:
city: Auckland
country: New Zealand
facility: Manukau Super clinic
city: Auckland
country: New Zealand
facility: Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial
Study officials:
affiliation: The University of Auckland
name: Michel K Nieuwoudt, PhD
role: PRINCIPAL_INVESTIGATOR
References: