ARTIficial Intelligence-based Smartphone Application for Skin Cancer Detection
ARTIS
Clinical Performance and Patient Experience of an Artificial Intelligence-based Smartphone Application (Skinvision ®) in the Early Detection of Skin Cancer: A Cross-Sectional Study in a Real-life Setting.
1 other identifier
observational
2,500
1 country
1
Brief Summary
The aim of this project is to assess whether a specific smartphone application (Skinvision App®) can be used as a tool to preselect skin lesions suspicious for skin cancer that require urgent medical advice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 17, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2025
CompletedJune 4, 2024
June 1, 2024
5.2 years
January 17, 2022
June 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic performance of the Skinvision application
To evaluate the sensitivity and specificity of the application. The risk assessment of the application will be compared to the gold standard. The gold standard is defined as the histopathologic diagnosis (in biopsied and excised lesions) or clinical assessment by one or two experienced dermatologists. The risk assessment of the application is defined as low (green), medium (orange) or high (red) risk. The biopsied or excised skin lesions will be categorized as benign or malignant.
Up to 24 months
Secondary Outcomes (3)
Usability and reproducibility of the Skinvision application
Up to 24 months
User's acceptability of medical smartphone applications
Day 1
User's confidence in using smartphone applications for skin cancer detection
Day 1
Other Outcomes (1)
Patient characteristics related to the use of (medical) smartphone applications
Day 1
Eligibility Criteria
Patients (\> 18 years old) consulting at the Department of Dermatology of the Ghent University Hospital concerned about one or two skin lesions meeting at least one of the specified criteria.
You may qualify if:
- Patients with one or two lesions meeting at least one of the following criteria:
- New mole in an adult (\> 18 years old);
- 'Ugly duckling' sign (i.e. mole that looks different from other moles in the same person)
- Changing mole (size, color, shape or structure);
- Rapid growing lesion
- Non-healing lesion
- Written informed consent of the patient
You may not qualify if:
- Lack of informed consent for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Ghent University Hospital
Ghent, East Flanders, 9000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lieve Brochez, MD, PhD
Ghent University Hospital, Department of Dermatology
- PRINCIPAL INVESTIGATOR
Evelien Verhaeghe, MD, PhD
Ghent University Hospital, Department of Dermatology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2022
First Posted
February 18, 2022
Study Start
January 1, 2020
Primary Completion
March 31, 2025
Study Completion
March 31, 2025
Last Updated
June 4, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share