<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03267069</url>
  </required_header>
  <id_info>
    <org_study_id>1601016922</org_study_id>
    <nct_id>NCT03267069</nct_id>
  </id_info>
  <brief_title>Evaluating Alcohol Use in Alcoholic Liver Disease</brief_title>
  <official_title>Evaluating Alcohol Use in Alcoholic Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicole T Shen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York Presbyterian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, analytic observational study will investigate alcohol recidivism in&#xD;
      patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver&#xD;
      disease are considered for inclusion. Subjects able to give consent are included.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver&#xD;
      disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell&#xD;
      Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the&#xD;
      Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a&#xD;
      survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10&#xD;
      years. Follow-up will consist of a chart review, a phone or in person interview, and most&#xD;
      recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded&#xD;
      to the survey results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2016</start_date>
  <completion_date type="Anticipated">November 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>alcohol recidivism assessed by questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Follow-up questionnaires will be administered at 6 months assessing for alcohol use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>alcohol recidivism assessed by clinical interview</measure>
    <time_frame>6 months</time_frame>
    <description>Follow-up interviews will be conducted at 6 months assessing for alcohol use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>alcohol recidivism assessed by urine ethyl glucuronide</measure>
    <time_frame>6 months</time_frame>
    <description>Follow-up urine testing may be conducted at 6 months assessing for alcohol use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>alcohol recidivism assessed by blood</measure>
    <time_frame>6 months</time_frame>
    <description>Follow-up blood testing may be conducted at 6 months assessing for alcohol use</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>alcohol recidivism assessed by questionnaire</measure>
    <time_frame>after 6 months</time_frame>
    <description>Follow-up questionnaires will be administered after 6 months assessing for alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alcohol recidivism assessed by clinical interview</measure>
    <time_frame>after 6 months</time_frame>
    <description>Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alcohol recidivism assessed by urine ethyl glucuronide</measure>
    <time_frame>after 6 months</time_frame>
    <description>Follow-up urine testing may be conducted after 6 months assessing for alcohol use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>alcohol recidivism assessed by blood</measure>
    <time_frame>after 6 months</time_frame>
    <description>Follow-up blood testing may be conducted after 6 months assessing for alcohol use</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Alcoholic Liver Disease</condition>
  <arm_group>
    <arm_group_label>alcohol liver disease</arm_group_label>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>survey</intervention_name>
    <description>surveys will be administered at inclusion and follow-ups</description>
    <arm_group_label>alcohol liver disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        subjects with alcoholic liver disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  alcoholic liver disease able to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without alcoholic liver disease unable to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert S Brown, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole T Shen, MD</last_name>
    <phone>3146095911</phone>
    <email>nts9004@nyp.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert S Brown, MD, MPH</last_name>
    <phone>(646) 962-5483</phone>
    <email>rsb2005@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole T Shen, MD</last_name>
      <phone>314-609-5911</phone>
      <email>nts9004@nyp.org</email>
    </contact>
    <contact_backup>
      <last_name>Cecilia M Mero</last_name>
      <phone>(646) 962-9358</phone>
      <email>cmm2002@med.cornell.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 11, 2019</last_update_submitted>
  <last_update_submitted_qc>March 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>New York Presbyterian Hospital</investigator_affiliation>
    <investigator_full_name>Nicole T Shen</investigator_full_name>
    <investigator_title>Gastroenterology and Hepatology Fellow Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Diseases, Alcoholic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03267069
org study id: 1601016922
nct id: NCT03267069
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: alcohol recidivism assessed by questionnaire
time frame: 6 months
description: Follow-up questionnaires will be administered at 6 months assessing for alcohol use
measure: alcohol recidivism assessed by clinical interview
time frame: 6 months
description: Follow-up interviews will be conducted at 6 months assessing for alcohol use
measure: alcohol recidivism assessed by urine ethyl glucuronide
time frame: 6 months
description: Follow-up urine testing may be conducted at 6 months assessing for alcohol use
measure: alcohol recidivism assessed by blood
time frame: 6 months
description: Follow-up blood testing may be conducted at 6 months assessing for alcohol use
measure: alcohol recidivism assessed by questionnaire
time frame: after 6 months
description: Follow-up questionnaires will be administered after 6 months assessing for alcohol use
measure: alcohol recidivism assessed by clinical interview
time frame: 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
time frame: after 6 months
description: Follow-up urine testing may be conducted after 6 months assessing for alcohol use
measure: alcohol recidivism assessed by blood
time frame: after 6 months
description: Follow-up blood testing may be conducted after 6 months assessing for alcohol use
arm group 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.
intervention type: Other
intervention name: survey
description: surveys will be administered at inclusion and follow-ups
arm group label: alcohol liver disease
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Robert S Brown, MD, MPH
role: Principal Investigator
affiliation: New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
last name: Nicole T Shen, MD
phone: 3146095911
email: nts9004@nyp.org
last name: Robert S Brown, MD, MPH
phone: (646) 962-5483
email: rsb2005@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: New York Presbyterian Hospital
investigator full name: Nicole T Shen
investigator title: Gastroenterology and Hepatology Fellow Physician
mesh term: Liver Diseases
mesh term: Liver Diseases, Alcoholic
sharing ipd: No