Skin Cancer MelanomaSkin CancerNCT07144306
AI-Driven Early Detection of Skin Cancer
An observational study of Skin Cancer Melanoma, run by Nuvana Healthcare LTD at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer Melanoma
- What is being tested?
- Smartphone-based AI skin lesion analysis (NuvanaDx platform).
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2025to 1 Jan 2026
- How long will I take part?
- 50 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study Population Description: Individuals undergoing dermatology evaluation in UK clinics, supplemented by retrospective anonymized image datasets.
Who may be able to join
- Adults (≥18 years) presenting with skin lesions suspicious for malignancy.
- Ability to provide informed consent.
Who cannot join
- Inability to provide informed consent.
- Poor-quality images unsuitable for AI analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuvana Healthcare Ltd
London
Sushma Saxena, B.Tech, Msci, +44 7481986525, sushma.saxena@nuvana.co.uk
Aryan Chaudhary
About this study
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.
Read the detailed description
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.
- Conditions
- Skin Cancer Melanoma
- Being tested
- Smartphone-based AI skin lesion analysis (NuvanaDx platform).
- Keywords
- Skin Cancer, Melanoma, Early Detection, Artificial Intelligence, Dermatology, Digital Health
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based AI skin lesion analysis (NuvanaDx platform).Diagnostic test
Smartphone-based AI skin lesion analysis (NuvanaDx platform).
| Study group | Role | What they receive |
|---|---|---|
| Participants with suspicious skin lesions undergoing AI-based image analysis and dermatologist confi | Not described Receives: Diagnostic Test: Smartphone-based AI skin lesion analysis (NuvanaDx platform). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 50 Months
Sponsor and investigators
- Lead sponsor
- Nuvana Healthcare LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Aryan Chaudhary,, Study chair, Scientific Advisor / Co-Founder, Nuvana Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144306
- Sponsor's protocol ID
- 70148
- Other IDs
- 359904
- Acronym
- Skin Cancer
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Early Detection of Skin Cancer
- ClinicalTrials.gov ID
- NCT07144306
- Acronym / sponsor ID
- Skin Cancer / 70148
- Conditions
- Skin Cancer Melanoma
- Keywords
- Skin Cancer, Melanoma, Early Detection, Artificial Intelligence, Dermatology, Digital Health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nuvana Healthcare LTDIndustry (pharma, biotech, devices)
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 50 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with suspicious skin lesions undergoing AI-based image analysis and dermatologist confi | – | Diagnostic Test: Smartphone-based AI skin lesion analysis (NuvanaDx platform). |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population Description: Individuals undergoing dermatology evaluation in UK clinics, supplemented by retrospective anonymized image datasets.
Key inclusion criteria (2 listed)
- Adults (≥18 years) presenting with skin lesions suspicious for malignancy.
- Ability to provide informed consent.
Key exclusion criteria (2 listed)
- Inability to provide informed consent.
- Poor-quality images unsuitable for AI analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based AI skin lesion analysis (NuvanaDx platform).Smartphone-based AI skin lesion analysis (NuvanaDx platform). | Diagnostic test | Participants with suspicious skin lesions undergoing AI-based image analysis and dermatologist confi |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aryan Chaudhary, study chair
Scientific Advisor / Co-Founder, Nuvana Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer Melanoma, run by Nuvana Healthcare LTD at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sushma Saxena, Director, Nuvana Healthcare Ltd (+44 7481986525, sushma.saxena@nuvana.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of AI tool compared with dermatologist-confirmed diagnosis (time frame: Time Frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.