Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-01-04 @ 2:30 AM
Study NCT ID:
NCT03858920
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2018-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Liver in the World Trade Center Health Program General Responder Cohort and Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-09', 'studyFirstSubmitDate': '2018-02-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FibroScan- Controlled Attenuation Parameter (CAP) scores', 'timeFrame': 'Day 1', 'description': 'assesses liver fat using a patented technique called Vibration-Controlled Transient Elastography range from 0 -400 CAP with the higher number indicating great quantity of fat in the Liver CAP 240-270 S1 Mild Steatosis CAP 270-300 S2 Moderate Steatosis CAP \\>300 S3 Severe Steatosis'}, {'measure': 'Attenuation Hounsfeld units signal intensity in low -dose non-contrast CT scan', 'timeFrame': 'Day 1', 'description': 'The attenuation of Hounsfeld units (HU) signal intensity in low-dose non-contrast CT to estimate liver fibrosis'}, {'measure': 'Fibroscan', 'timeFrame': 'Day 1', 'description': "assesses liver stiffness using a patented technique called Vibration-Controlled Transient Elastography. Results are measured using kiloPascal's (or kPa) and range from 2 to 75kPa, with a higher number indicating more liver scarring.\n\nF0 Zero 5.3 kPa means no scarring F1 5.3-7.0 kPa is mild fibrosis F2 is 7.1-8.0 kPa moderate fibrosis F3 8.1-12.4 kPa is severe fibrosis F4 greater than 12.5 kPa is cirrhosis or advanced fibrosis,"}], 'secondaryOutcomes': [{'measure': 'Relationship between WTC exposure and liver fat', 'timeFrame': 'Day 1', 'description': 'The Controlled Attenuation Parameter (CAP) scores using a Multiple linear regression modeling to determine whether WTC exposure is significantly associated with liver fat content after adjusting for potential confounding factors ,smoking history, diabetes and BMI.'}, {'measure': 'Composite score for Fibrosis and Steatosis', 'timeFrame': 'Day 1', 'description': 'Composite score from Fibroscan to compare for exposure to WTC site Clinically significant fibrosis will be defined as Fibroscan \\>8.0kPa and Steatosis will be defined as a Fibroscan CAP \\>300dB/m indicating advance steatosis \\<7.9 kPa score Zero , \\>8.0 kPa score 1, \\<299 CAP will score Zero, \\>300 CAP will score 1 Range of total score Zero -2 equals best to worst scoring'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Steatosis of Liver', 'NASH - Nonalcoholic Steatohepatitis']}, 'descriptionModule': {'briefSummary': 'This project investigates whether exposure to the World Trade Center Attack is a risk factor for liver injury.', 'detailedDescription': 'This is a prospective cross-sectional study of liver disease in individuals who meet the United States Preventive Services Task Forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. Liver disease will be compared between individuals who are members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort. The basic objective is to determine whether exposure to the WTC attack increased liver disease.\n\nData will be obtained from the World Trade Center Data Center, from Mount Sinai Medical records, EPIC, the data warehouse, and from data collected by the Lung Cancer Screening Program of Dr. Henschke. Results of genetic tests that relate to liver disease will be collected from the medical record.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Members of the World Trade Center General Responder Cohort and individuals who are not members of this cohort.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female between 55 and 80 years of age\n* 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years.\n* Individuals who are members of the World Trade Center General Responder Cohort or Subjects who meet the United States Preventive Services Task Forces guidelines for lung cancer screening\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03858920', 'briefTitle': 'The Liver in the World Trade Center Health Program General Responder Cohort and Controls', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Liver in the World Trade Center Health Program General Responder Cohort and Controls', 'orgStudyIdInfo': {'id': 'GCO 16-2612'}, 'secondaryIdInfos': [{'id': 'U01OH011489-01', 'link': 'https://reporter.nih.gov/quickSearch/U01OH011489-01', 'type': 'NIH'}, {'id': 'IF 1991038', 'type': 'OTHER', 'domain': 'Icahn School of Medicine at Mount Sinai'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Responder Cohort (GRC) WTC Responders', 'description': "General Responder Cohort (GRC) and who have chosen to undergo annual medical monitoring and treatment of their WTC-related conditions at Mount Sinai's Irving J. Selikoff Center for Occupational and Environmental Medicine (SCOEM), which is directed by Dr. M. Crane", 'interventionNames': ['Device: Fibroscan of Liver', 'Procedure: Low-dose non-contrast CT']}, {'label': 'General Responder Cohort (GRC) Non WTC Responders', 'description': 'Members of the World Trade Center General Non Responder Cohort.', 'interventionNames': ['Device: Fibroscan of Liver', 'Procedure: Low-dose non-contrast CT']}], 'interventions': [{'name': 'Fibroscan of Liver', 'type': 'DEVICE', 'otherNames': ['FibroScan Test'], 'description': 'A non-invasive diagnostic device used to measure liver scarring', 'armGroupLabels': ['General Responder Cohort (GRC) Non WTC Responders', 'General Responder Cohort (GRC) WTC Responders']}, {'name': 'Low-dose non-contrast CT', 'type': 'PROCEDURE', 'description': 'CT scan as part of routine research care', 'armGroupLabels': ['General Responder Cohort (GRC) Non WTC Responders', 'General Responder Cohort (GRC) WTC Responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Andrea Branch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Branch', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}