Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer

Skin Cancer Clinical Trial

— DermScan  

Official title:

DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03818620
• Other study ID #: CI-PROT-0010
• Secondary ID: B32220173245780M
• Status: Recruiting
• Start date: June 7, 2017
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Barco NV
• Contact: Hannah Manssens
• Phone: 056 26 2609
• Email: hannah.manssens[@]barco.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multicenter prospective observational clinical investigation with a medical device. The purpose of this study is to develop and validate of a new type of digital dermatoscope with automatic decision support algorithms. By means of this study a better insight can be gained of the current performance and workflow in clinical dermatoscopy. This knowledge will be used to further improve the developed technology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient has a lesion that is accessible to the Barco Digital Dermatoscope
• Patient gives informed consent
• Men or women of any ethnic group aged = 18 years

Exclusion Criteria:

• Men or women of any ethnic group aged < 18 years
• Patients not willing or able to read, understand and sign the study-specific informed consent form

Related Conditions & MeSH terms

• Skin Cancer
• Skin Diseases
• Skin Neoplasms

Intervention

Device:
• Barco digital dermatoscope device images
Images of skin lesion taken with the Barco dermatoscope by site team member
• Reference standard dermatoscope device images
Images of skin lesion taken with a standard dermatoscope device (as part of standard care)

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	UZ / KU Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Barco NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI	Database of multispectral images of potential skin cancer lesions acquired with the Barco device together with clinical information (e.g. age, gender, history of skin cancer, histopathology diagnosis) and matched standard images using medical photography	3.5 years
Secondary	Comparison of new device to standard dermoscopy	Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)	2 years