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

NCT03818620 | Active Not Recruiting

• 3 other identifiers: CI-PROT-0010B32220173245780M0675
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Skin Cancer; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of new device to standard dermoscopy

  2 years

Interventions

Barco digital dermatoscope device images DEVICE

Images of skin lesion taken with the Barco dermatoscope by site team member

Reference standard dermatoscope device images DEVICE

Images of skin lesion taken with a standard dermatoscope device (as part of standard care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barco NV: lead

Study Sites (2)

UZ Gent

Ghent, 9000, Belgium

Location

UZ / KU Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Skin Neoplasms; Skin Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin and Connective Tissue Diseases

Study Officials

• Marjan Garmyn, Prof. Dr.

  UZ / KU Leuven

  PRINCIPAL INVESTIGATOR

• Lieve Brochez, Prof. Dr.

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 28, 2019
• Study Start: June 7, 2017
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)