Skin CancerDermScanNCT03818620
Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
An observational study of Skin Cancer and Skin Diseases, run by Barco NV at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Skin Diseases
- What is being tested?
- Barco digital dermatoscope device images and Reference standard dermatoscope device images
- Type of treatment
- Medical device
- How many people
- 4,339 participants
- Where
- 2 sitesBelgium
- Study dates
- 7 Jun 2017to 15 May 2025
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Skin Cancer, Skin Diseases
- Being tested
- Barco digital dermatoscope device images, Reference standard dermatoscope device images
- Medical subject headings
- Skin Neoplasms, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barco digital dermatoscope device imagesDevice
Images of skin lesion taken with the Barco dermatoscope by site team member
Reference standard dermatoscope device imagesDevice
Images of skin lesion taken with a standard dermatoscope device (as part of standard care)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3.5 years
Secondary outcomes (1)
Comparison of new device to standard dermoscopy
Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start7 Jun 2017
- Primary completion7 Jun 2023
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barco NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marjan Garmyn, Prof. Dr., Principal investigator, UZ / KU LeuvenLieve Brochez, Prof. Dr., Principal investigator, UZ Gent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818620
- Sponsor's protocol ID
- CI-PROT-0010
- Other IDs
- B322201732457, 80M0675
- Acronym
- DermScan
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2019
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No