Alcoholic Liver DiseaseNCT03267069
Evaluating Alcohol Use in Alcoholic Liver Disease
An observational study of Alcoholic Liver Disease, run by Nicole T Shen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcoholic Liver Disease
- What is being tested?
- survey
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2016to 1 Nov 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects with alcoholic liver disease
Who may be able to join
- alcoholic liver disease able to consent
Who cannot join
- without alcoholic liver disease unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
New York, New York, 10021
Nicole T Shen, MD, 314-609-5911, nts9004@nyp.org
Cecilia M Mero, (646) 962-9358, cmm2002@med.cornell.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Alcoholic Liver Disease
- Being tested
- survey
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyOther
surveys will be administered at inclusion and follow-ups
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol recidivism assessed by questionnaire
Follow-up questionnaires will be administered at 6 months assessing for alcohol use
Measured: 6 months
alcohol recidivism assessed by clinical interview
Follow-up interviews will be conducted at 6 months assessing for alcohol use
Measured: 6 months
alcohol recidivism assessed by urine ethyl glucuronide
Follow-up urine testing may be conducted at 6 months assessing for alcohol use
Measured: 6 months
alcohol recidivism assessed by blood
Follow-up blood testing may be conducted at 6 months assessing for alcohol use
Measured: 6 months
Secondary outcomes (4)
alcohol recidivism assessed by questionnaire
Follow-up questionnaires will be administered after 6 months assessing for alcohol use
Measured: after 6 months
alcohol recidivism assessed by clinical interview
Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use
Measured: after 6 months
alcohol recidivism assessed by urine ethyl glucuronide
Follow-up urine testing may be conducted after 6 months assessing for alcohol use
Measured: after 6 months
alcohol recidivism assessed by blood
Follow-up blood testing may be conducted after 6 months assessing for alcohol use
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start27 Nov 2016
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Nicole T Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole T Shen, New York Presbyterian Hospital
- Investigators
- Robert S Brown, MD, MPH, Principal investigator, New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267069
- Sponsor's protocol ID
- 1601016922
- Status last verified
- Mar 2019
- First submitted
- 21 Aug 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37126326
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Alcohol Use in Alcoholic Liver Disease
- ClinicalTrials.gov ID
- NCT03267069
- Acronym / sponsor ID
- 1601016922
- Conditions
- Alcoholic Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nicole T ShenUniversity, hospital or other
- Study start
- 27 Nov 2016 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| alcohol liver disease | – | Other: surveyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects with alcoholic liver disease
Key inclusion criteria (1 listed)
- alcoholic liver disease able to consent
Key exclusion criteria (1 listed)
- without alcoholic liver disease unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveysurveys will be administered at inclusion and follow-ups | Other | alcohol liver disease |
Primary outcome
alcohol recidivism assessed by questionnaire
Time frame: 6 months
Follow-up questionnaires will be administered at 6 months assessing for alcohol use
alcohol recidivism assessed by clinical interview
Time frame: 6 months
Follow-up interviews will be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by urine ethyl glucuronide
Time frame: 6 months
Follow-up urine testing may be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by blood
Time frame: 6 months
Follow-up blood testing may be conducted at 6 months assessing for alcohol use
4 secondary outcomes
alcohol recidivism assessed by questionnaire
Time frame: after 6 months
alcohol recidivism assessed by clinical interview
Time frame: after 6 months
alcohol recidivism assessed by urine ethyl glucuronide
Time frame: after 6 months
alcohol recidivism assessed by blood
Time frame: after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 37126326Fahoum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert S Brown, MD, MPH principal investigator
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Liver Disease, run by Nicole T Shen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole T Shen, MD (3146095911, nts9004@nyp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol recidivism assessed by questionnaire (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.