Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-24 @ 2:55 PM
Study NCT ID:
NCT03818620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-05
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of anonymized database with over 3000 (potential) skin cancer cases for use in AI', 'timeFrame': '3.5 years', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Comparison of new device to standard dermoscopy', 'timeFrame': '2 years', 'description': 'Compare clinical performance and workflow efficiency of the Barco device to current standard of care (standard dermoscopy)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Cancer', 'Skin Diseases']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has a lesion that is accessible to the Barco Digital Dermatoscope\n* Patient gives informed consent\n* Men or women of any ethnic group aged ≥ 18 years\n\nExclusion Criteria:\n\n* Men or women of any ethnic group aged \\< 18 years\n* Patients not willing or able to read, understand and sign the study-specific informed consent form'}, 'identificationModule': {'nctId': 'NCT03818620', 'acronym': 'DermScan', 'briefTitle': 'Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Barco NV'}, 'officialTitle': 'DermScan - Research in the Development of a New Type of Digital Dermatoscope for Skin Cancer', 'orgStudyIdInfo': {'id': 'CI-PROT-0010'}, 'secondaryIdInfos': [{'id': 'B322201732457', 'type': 'OTHER', 'domain': 'Belgian registration number'}, {'id': '80M0675', 'type': 'OTHER', 'domain': 'FAMHP Belgium'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Barco digital dermatoscope device images', 'type': 'DEVICE', 'description': 'Images of skin lesion taken with the Barco dermatoscope by site team member'}, {'name': 'Reference standard dermatoscope device images', 'type': 'DEVICE', 'description': 'Images of skin lesion taken with a standard dermatoscope device (as part of standard care)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ / KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marjan Garmyn, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ / KU Leuven'}, {'name': 'Lieve Brochez, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Gent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barco NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}