Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02376920
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'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': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-13', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay', 'timeFrame': 'Approximately 3-6 weeks after biopsy of uveal tumor', 'description': 'Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern'}, {'measure': 'Time to metastasis', 'timeFrame': 'Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals'}], 'secondaryOutcomes': [{'measure': 'changes in health care costs', 'timeFrame': 'Patients followed for up to 10 years at 6 month intervals', 'description': 'review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['occular melanoma', 'melanoma of eye', 'DecisionDx-UM'], 'conditions': ['Uveal Melanoma']}, 'referencesModule': {'references': [{'pmid': '27446211', 'type': 'DERIVED', 'citation': 'Plasseraud KM, Cook RW, Tsai T, Shildkrot Y, Middlebrook B, Maetzold D, Wilkinson J, Stone J, Johnson C, Oelschlager K, Aaberg TM. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762. doi: 10.1155/2016/5325762. Epub 2016 Jun 30.'}]}, 'descriptionModule': {'briefSummary': "Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of Uveal Melanoma\n* Patients whose physician deems them appropriate for DecisionDx-UM testing\n* Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data\n\nExclusion Criteria:\n\n* Patients with any other form of cancer'}, 'identificationModule': {'nctId': 'NCT02376920', 'acronym': 'CLEAR', 'briefTitle': '5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Castle Biosciences Incorporated'}, 'officialTitle': 'CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.', 'orgStudyIdInfo': {'id': '2-01'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert Cook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Castle Biosciences Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Castle Biosciences Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}