Alcohol-related Liver DiseaseNCT01812226
Alcohol Biomarkers in Post-Liver Transplant Patients
An observational study of Alcohol-related Liver Disease, run by Northwestern University at 2 sites in United States.
Trial summary
The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-related Liver Disease
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Transplant center patients
Who may be able to join
- men and women 18 years and over
- Participant must have received a liver transplant after January 1, 2003
- Participant must be six months or more post-transplant
- Mini-mental status score of greater than or equal to 20
- Participant must be well enough to participate in the research procedures over a 12 month period
- Participant must continue to be followed by the transplant center
Who cannot join
- Individuals who do not consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Wisconsin, Madison
Madison, Wisconsin, 53792
About this study
The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Subjects enrolled in the study will be followed for 12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and depression. The six and 12 months interview will focus on previous 30 day alcohol use. The baseline, six and 12 months interviews will be conducted face-to-face at each site. While many patients who receive a transplant do not live near the academic medical center that performed the surgery patient, they normally have a transplant clinic visit 1-2 times per year. Medical records and transplant databases will be assessed to assess the other variables of interest.
Read the detailed description
Patients who have a positive PEth will be asked to have a confirmatory test performed 10-14 days after a positive result (PEth >20ng/ml). The rationale for this procedure is to determine the test retest reliability of this marker and as well as being able to correlate levels of drinking with changes in biomarker levels over time. There is limited information on the length of time PEth levels remain elevated in transplant patients after drinking episodes.
Hypothesis H.1. PEth will have a significantly higher "area under the Receiver Operating Characteristic (ROC) curve" in a sample of post-transplant patients who report any alcohol use in the past 30 days compared to the control group.
H.2. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report daily alcohol use of >40 grams/day (three drinks/day) in the past 30 days compared to the control group.
H.3. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report heavy episodic drinking (>60 grams of alcohol, eight or more occasions in the past 30 days) compared to the control group.
H.4. PEth levels will be <20 ng/ml in the control sample of 50 post transplant patients who do not have a history of alcohol dependence or alcohol related liver disease.
H.5. The test-retest reliability of PEth will be >0.90.
- Conditions
- Alcohol-related Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | This group will consist of men and women who received a liver transplant for alcohol-related liver disease. | |
| control group | This group will consist of men and women who had a liver transplant for reasons that are not alcohol-related. |
What is being measured
The primary outcome is the main question the study is designed to answer.
specificity of PEth to detect alcohol use among post-transplant patients
The criteria standard on which we will base the specificity will be a combination of patient self-report, family member report and clinician/medical record data.
Subjects in whom any concern of current alcohol use, from any of these sources, would be considered a positive for current drinking.
The PEth levels would then be compared to this standard of current alcohol use
Data from previous research suggests PEth has a specificity close to 100%
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fleming, Northwestern University
- Investigators
- Michael F Fleming, MD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812226
- Sponsor's protocol ID
- STU31235
- Status last verified
- Feb 2023
- First submitted
- 11 Mar 2013
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Biomarkers in Post-Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT01812226
- Acronym / sponsor ID
- STU31235
- Conditions
- Alcohol-related Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Mar 2013 (estimated)
- 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.
The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Subjects enrolled in the study will be followed for 12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and depression. The six and 12 months interview will focus on previous 30 day alcohol use. The baseline, six and 12 months interviews will be conducted face-to-face at each site. While many patients who receive a transplant do not live near the academic medical center that performed the surgery patient, they normally have a transplant clinic visit 1-2 times per year. Medical records and transplant databases will be assessed to assess the other variables of interest.
Detailed description
Patients who have a positive PEth will be asked to have a confirmatory test performed 10-14 days after a positive result (PEth >20ng/ml). The rationale for this procedure is to determine the test retest reliability of this marker and as well as being able to correlate levels of drinking with changes in biomarker levels over time. There is limited information on the length of time PEth levels remain elevated in transplant patients after drinking episodes.
Hypothesis H.1. PEth will have a significantly higher "area under the Receiver Operating Characteristic (ROC) curve" in a sample of post-transplant patients who report any alcohol use in the past 30 days compared to the control group.
H.2. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report daily alcohol use of >40 grams/day (three drinks/day) in the past 30 days compared to the control group.
H.3. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report heavy episodic drinking (>60 grams of alcohol, eight or more occasions in the past 30 days) compared to the control group.
H.4. PEth levels will be <20 ng/ml in the control sample of 50 post transplant patients who do not have a history of alcohol dependence or alcohol related liver disease.
H.5. The test-retest reliability of PEth will be >0.90.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –This group will consist of men and women who received a liver transplant for alcohol-related liver disease. |
| control group | – | –This group will consist of men and women who had a liver transplant for reasons that are not alcohol-related. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Transplant center patients
Key inclusion criteria (6 listed)
- men and women 18 years and over
- Participant must have received a liver transplant after January 1, 2003
- Participant must be six months or more post-transplant
- Mini-mental status score of greater than or equal to 20
- Participant must be well enough to participate in the research procedures over a 12 month period
Key exclusion criteria (1 listed)
- Individuals who do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
specificity of PEth to detect alcohol use among post-transplant patients
Time frame: 12 month follow up
The criteria standard on which we will base the specificity will be a combination of patient self-report, family member report and clinician/medical record data. Subjects in whom any concern of current alcohol use, from any of these sources, would be considered a positive for current drinking. The PEth levels would then be compared to this standard of current alcohol use Data from previous research suggests PEth has a specificity close to 100%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- 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. This study is not recruiting at the moment.
Michael F Fleming, MD, MPH principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol-related Liver Disease, run by Northwestern University at 2 sites 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 6 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: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specificity of PEth to detect alcohol use among post-transplant patients (time frame: 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2023.