This study evaluates the feasibility and accuracy of an AI-powered mobile platform (NuvanaDx) for early detection of skin cancer, including melanoma, using smartphone-based imaging. The platform is designed to improve access to early diagnosis, reduce waiting times, and support triage into appropriate care pathways.

The study will collect retrospective and prospective anonymized skin lesion images and metadata to validate the AI algorithm against dermatology-confirmed diagnoses. The aim is to determine sensitivity, specificity, and predictive value of the AI tool across diverse populations and skin tones. The study will also assess user experience, accessibility, and integration into clinical care pathways.

Inclusion Criteria:

Adults (≥18 years) presenting with skin lesions suspicious for malignancy.

Ability to provide informed consent.

Exclusion Criteria:

Inability to provide informed consent.

Poor-quality images unsuitable for AI analysis.

Study Population Description: Individuals undergoing dermatology evaluation in UK clinics, supplemented by retrospective anonymized image datasets.

Individual Participant Data (IPD) that underlie the results of this study will be shared after de-identification. This will include anonymized image datasets of skin lesions (with corresponding dermatology-confirmed diagnoses), demographic variables (age, sex), and relevant clinical outcomes. No personally identifiable information (PII) will be shared. Data will be made available for the purpose of secondary analysis, validation studies, and meta-analyses in the field of dermatology, oncology, and digital health.

De-identified IPD and supporting information will be available beginning 6 months after study completion (anticipated June 2027). Data will remain available for at least 5 years (until December 2032), after which access will be reviewed and may be extended based on scientific demand.

Access will be granted to qualified researchers affiliated with academic institutions, non-profit organizations, or healthcare systems, upon submission of a research proposal that aligns with the study's objectives. Proposals will be reviewed by Nuvana Healthcare's Scientific Advisory Board. Data will be shared under a data use agreement (DUA) to ensure confidentiality and compliance with ethical standards. Access will be provided through a secure, password-protected platform, with no download of raw datasets permitted unless explicitly approved.