Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-01-04 @ 5:28 PM
Study NCT ID:
NCT03800069
Status:
TERMINATED
Last Update Posted:
2020-12-04
First Post:
2019-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Point of Care Liver Function Tests
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-28', 'size': 502056, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-09T09:52', 'hasProtocol': True}, {'date': '2018-11-28', 'size': 312290, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-01-09T09:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'scheduling complexities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2019-01-07', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regression curve and correlation coefficient', 'timeFrame': '1 year', 'description': "Each data point will represent one observation or one test run. The investigators will use regression methods to determine the linear relationship between standard lab results and Group K diagnostic's device."}], 'secondaryOutcomes': [{'measure': 'The consistent accuracy of the diagnostic device', 'timeFrame': '1 year', 'description': 'Lowest level frequency of detection must be detected 90% of the time. This will become the functional lower limit. The same with the highest level of frequency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases', 'Healthy', 'Cirrhosis, Liver', 'Fibrosis']}, 'descriptionModule': {'briefSummary': 'This study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.', 'detailedDescription': 'Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.\n\nGroup K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from inpatient and clinic setting at The Hospital of the University of Pennsylvania.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein)\n* 18 years or older\n\nExclusion Criteria:\n\n* Inadequate blood sample obtained from finger stick\n* Inconclusive liver function testing\n* Not all 6 liver tests completed on the same sample\n* Liver tests not drawn for normal method at same time as finger stick.'}, 'identificationModule': {'nctId': 'NCT03800069', 'briefTitle': 'Validation of Point of Care Liver Function Tests', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Biomedical Device Trial of Validation of Point of Care Liver Function Tests', 'orgStudyIdInfo': {'id': '829476'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm 1', 'description': 'A finger stick sample is collected and tested on the study device.', 'interventionNames': ['Device: Group K Diagnostic point of care device']}], 'interventions': [{'name': 'Group K Diagnostic point of care device', 'type': 'DEVICE', 'description': 'Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Hospital of the University of Pennslyvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Vandana Khungar, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Inpatient Hepatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Group K Diagnostics Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}