Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-28 @ 5:33 AM
Study NCT ID:
NCT03267069
Status:
RECRUITING
Last Update Posted:
2019-03-13
First Post:
2017-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Alcohol Use in Alcoholic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alcohol recidivism assessed by questionnaire', 'timeFrame': '6 months', 'description': 'Follow-up questionnaires will be administered at 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by clinical interview', 'timeFrame': '6 months', 'description': 'Follow-up interviews will be conducted at 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by urine ethyl glucuronide', 'timeFrame': '6 months', 'description': 'Follow-up urine testing may be conducted at 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by blood', 'timeFrame': '6 months', 'description': 'Follow-up blood testing may be conducted at 6 months assessing for alcohol use'}], 'secondaryOutcomes': [{'measure': 'alcohol recidivism assessed by questionnaire', 'timeFrame': 'after 6 months', 'description': 'Follow-up questionnaires will be administered after 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by clinical interview', 'timeFrame': 'after 6 months', 'description': 'Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by urine ethyl glucuronide', 'timeFrame': 'after 6 months', 'description': 'Follow-up urine testing may be conducted after 6 months assessing for alcohol use'}, {'measure': 'alcohol recidivism assessed by blood', 'timeFrame': 'after 6 months', 'description': 'Follow-up blood testing may be conducted after 6 months assessing for alcohol use'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcoholic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '37126326', 'type': 'DERIVED', 'citation': 'Fahoum K, Shen NT, Basu E, Lee J, Kaplan A, Salajegheh A, Rosenblatt R, Jesudian A, Lucero C, Fortune B, Safford M, Brown RS Jr. Prognostic Factors in Alcohol-associated Liver Disease Patients Presenting With First Evidence of Ascites. J Clin Gastroenterol. 2024 Feb 1;58(2):200-206. doi: 10.1097/MCG.0000000000001836.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.', 'detailedDescription': 'This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'subjects with alcoholic liver disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* alcoholic liver disease able to consent\n\nExclusion Criteria:\n\n* without alcoholic liver disease unable to consent'}, 'identificationModule': {'nctId': 'NCT03267069', 'briefTitle': 'Evaluating Alcohol Use in Alcoholic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'New York Presbyterian Hospital'}, 'officialTitle': 'Evaluating Alcohol Use in Alcoholic Liver Disease', 'orgStudyIdInfo': {'id': '1601016922'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'alcohol liver disease', 'description': 'Patients with alcohol liver disease consenting to participate in the study will be administered an initial survey at inclusion and then follow-up surveys at 3, 6, 9, 12, 15, and 18 month intervals and then 2, 5, and 10 years. There is no intervention cohort, all enrolled will complete the same surveys. Recidivism will be measured by responses to survey questions, clinical interviews documented in the chart, and urine ethnyl glucuronide or blood ethanol testing.', 'interventionNames': ['Other: survey']}], 'interventions': [{'name': 'survey', 'type': 'OTHER', 'description': 'surveys will be administered at inclusion and follow-ups', 'armGroupLabels': ['alcohol liver disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole T Shen, MD', 'role': 'CONTACT', 'email': 'nts9004@nyp.org', 'phone': '314-609-5911'}, {'name': 'Cecilia M Mero', 'role': 'CONTACT', 'email': 'cmm2002@med.cornell.edu', 'phone': '(646) 962-9358'}], 'facility': 'New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Nicole T Shen, MD', 'role': 'CONTACT', 'email': 'nts9004@nyp.org', 'phone': '3146095911'}, {'name': 'Robert S Brown, MD, MPH', 'role': 'CONTACT', 'email': 'rsb2005@med.cornell.edu', 'phone': '(646) 962-5483'}], 'overallOfficials': [{'name': 'Robert S Brown, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nicole T Shen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gastroenterology and Hepatology Fellow Physician', 'investigatorFullName': 'Nicole T Shen', 'investigatorAffiliation': 'New York Presbyterian Hospital'}}}}