NCT03267069

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Nov 2016Nov 2027

Study Start

First participant enrolled

November 27, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

9.9 years

First QC Date

August 21, 2017

Last Update Submit

March 11, 2019

Conditions

Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (4)

  • alcohol recidivism assessed by questionnaire

    Follow-up questionnaires will be administered at 6 months assessing for alcohol use

    6 months

  • alcohol recidivism assessed by clinical interview

    Follow-up interviews will be conducted at 6 months assessing for alcohol use

    6 months

  • alcohol recidivism assessed by urine ethyl glucuronide

    Follow-up urine testing may be conducted at 6 months assessing for alcohol use

    6 months

  • alcohol recidivism assessed by blood

    Follow-up blood testing may be conducted at 6 months assessing for alcohol use

    6 months

Secondary Outcomes (4)

  • alcohol recidivism assessed by questionnaire

    after 6 months

  • alcohol recidivism assessed by clinical interview

    after 6 months

  • alcohol recidivism assessed by urine ethyl glucuronide

    after 6 months

  • alcohol recidivism assessed by blood

    after 6 months

Study Arms (1)

alcohol liver disease

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.

Other: survey

Interventions

surveyOTHER

surveys will be administered at inclusion and follow-ups

alcohol liver disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects with alcoholic liver disease

You may qualify if:

  • alcoholic liver disease able to consent

You may not qualify if:

  • without alcoholic liver disease unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

New York, New York, 10021, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37126326DERIVED

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Robert S Brown, MD, MPH

    New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole T Shen, MD

CONTACT

3146095911nts9004@nyp.org

Robert S Brown, MD, MPH

CONTACT

(646) 962-5483rsb2005@med.cornell.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastroenterology and Hepatology Fellow Physician

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 30, 2017

Study Start

November 27, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)