Clinical Trial Finder

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

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.#46;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.

Arms

: 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

Interventions