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

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Sufficient numbers of measurements to achieve an acceptable area under the ROC curve (AUCROC) for accurate differentiation between benign skin conditions and skin cancers [Срок оценки: Day 1, baseline, 12 months]

Вторичные конечные точки (1)

• Number of participants with adverse events and descriptions of adverse events [Срок оценки: Day 1, baseline, 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Новая Зеландия · 2 центра

• Manukau Super clinic — Auckland
• Sir Willliam Manchester Plastic surgery suite, Middlemore Hosptial — Auckland

Идентификаторы

NCT: NCT06661577 · HDEC21297 · HDEC 21297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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