AI-Driven Early Detection of Skin Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Months and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07144306
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nuvana Healthcare LTD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Aryan Chaudhary,
Principal Investigator Affiliation	Scientific Advisor / Co-Founder, Nuvana Healthcare
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Skin Cancer Melanoma

Additional Details

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.

Arms & Interventions

Arms

: Participants with suspicious skin lesions undergoing AI-based image analysis and dermatologist confi

Interventions

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

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Sushma Saxena, Director, Nuvana Healthcare Ltd

[email protected]

+44 7481986525

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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