Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-04-11 @ 10:04 PM
Study NCT ID:
NCT01556503
Status:
COMPLETED
Last Update Posted:
2016-04-25
First Post:
2012-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-21', 'studyFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2012-03-14', 'lastUpdatePostDateStruct': {'date': '2016-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of confocal microscope to improve melanoma detection', 'timeFrame': 'Up to 1 year', 'description': 'Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.'}, {'measure': 'Specificity of the confocal microscope to improve melanoma detection', 'timeFrame': 'Up to 1 year', 'description': 'Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis'}], 'secondaryOutcomes': [{'measure': 'Patterns seen on the confocal image', 'timeFrame': 'Up to 1 year', 'description': 'Evaluate and confirm patterns seen on the confocal image, which are characteristic of melanoma and atypical nevi:\n\nA) Pagetoid melanoma cells: melanocytes in suprabasal areas of the epidermis B) Irregular dermal-epidermal junction'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 12 or older\n* Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\< 12 years'}, 'identificationModule': {'nctId': 'NCT01556503', 'briefTitle': 'Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis', 'orgStudyIdInfo': {'id': 'IRB00006939'}, 'secondaryIdInfos': [{'id': 'CPC-11033-L', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pigmented Lesion', 'description': 'Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.', 'interventionNames': ['Device: VivaScope System']}], 'interventions': [{'name': 'VivaScope System', 'type': 'DEVICE', 'otherNames': ['Confocal Microscope'], 'description': 'VivaScope System, Model#s 1500 and 2500', 'armGroupLabels': ['Pigmented Lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'OHSU Knight Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Eric Simpson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}