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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Skin Diseases; Skin Cancer
• Intervention / Treatment: Device: Barco digital dermatoscope device images; Device: Reference standard dermatoscope device images

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ / KU Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients will be considered for enrollment in the study when they have a lesion that is accessible to the Barco Digital Dermatoscope, are able to give informed consent and are over 18 years old.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Barco NV
• Investigators: Principal Investigator: Marjan Garmyn, Prof. Dr., UZ / KU Leuven; Principal Investigator: Lieve Brochez, Prof. Dr., UZ Gent

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Neoplasms; Skin Diseases
• Other Study ID Numbers: CI-PROT-0010; B322201732457 (Other Identifier: Belgian registration number); 80M0675 (Other Identifier: FAMHP Belgium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No