NCT07144306

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 20, 2025

Last Update Submit

September 25, 2025

Conditions

Skin Cancer Melanoma

Keywords

Skin CancerMelanomaEarly DetectionArtificial IntelligenceDermatologyDigital Health

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis

    Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis Time Frame: Up to 12 months Measure: Sensitivity, specificity, and predictive values

    Time Frame: Up to 12 months

Study Arms (1)

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

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

Interventions

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

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

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

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adults (≥18 years) presenting with skin lesions suspicious for malignancy.
  • Ability to provide informed consent.

You may not qualify if:

  • Inability to provide informed consent.
  • Poor-quality images unsuitable for AI analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuvana Healthcare Ltd

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aryan Chaudhary,

    Scientific Advisor / Co-Founder, Nuvana Healthcare

    STUDY CHAIR

Central Study Contacts

Sushma Saxena, Director, Nuvana Healthcare Ltd

CONTACT

+44 7481986525sushma.saxena@nuvana.co.uk

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
50 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 27, 2025

Study Start

October 1, 2025

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
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 Criteria
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.
More information

Locations

GB(1)