Recruiting

NCT Number: NCT07144306

AI-Driven Early Detection of Skin Cancer

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.

Recruiting

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Key information

Conditions

Skin Cancer Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nuvana Healthcare Ltd

London, United Kingdom

Location status: Recruiting

Location contact

Aryan Chaudhary

PRINCIPAL_INVESTIGATOR

Sushma Saxena, B.Tech, Msci

CONTACT

[email protected]

+44 7481986525

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone-based AI skin lesion analysis (NuvanaDx platform).

Diagnostic Test

Smartphone-based AI skin lesion analysis (NuvanaDx platform).

Primary outcomes

Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis

Time frame: Time Frame: Up to 12 months

Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis

Time Frame: Up to 12 months

Measure: Sensitivity, specificity, and predictive values

Study contacts

Contact information is provided by the study sponsor or research team.

Sushma Saxena, Director, Nuvana Healthcare Ltd

CONTACT

[email protected]

+44 7481986525

Sponsors and collaborators

Lead sponsor

Nuvana Healthcare LTD

Industry

Collaborators

National Institute for Health Research, United Kingdom

Registry information

Acronym: Skin Cancer

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Aug 27, 2025
Registry last updated: Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting