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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
- ClinicalTrials.gov ID
- NCT03818620
- Acronym / sponsor ID
- DermScan / CI-PROT-0010
- Conditions
- Skin Cancer, Skin Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,339 participants (actual)
- Lead sponsor
- Barco NVIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barco digital dermatoscope device imagesImages of skin lesion taken with the Barco dermatoscope by site team member | Device | – |
| Reference standard dermatoscope device imagesImages of skin lesion taken with a standard dermatoscope device (as part of standard care) | Device | – |
Primary outcome
Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI
Time frame: 3.5 years
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
1 secondary outcome
Comparison of new device to standard dermoscopy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
Related trials for Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjan Garmyn, Prof. Dr. principal investigator
UZ / KU Leuven
Lieve Brochez, Prof. Dr. principal investigator
UZ Gent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer and Skin Diseases, run by Barco NV at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.