Non-alcoholic Fatty Liver DiseaseNCT03128918
Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients
An observational study of Non-alcoholic Fatty Liver Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantation is a life-saving procedure for people with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Sep 2017
- 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: post liver transplant
Who may be able to join
- Liver transplant recipient of any etiology;
- >18 years old;
- Able to provide informed consent.
Who cannot join
- Liver transplant due to alcoholic liver disease as primary etiology;
- Liver transplant due to chronic hepatitis C, genotype 3.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Mcgill University Health Center
Montreal, Quebec, H4A 3J1
Maria Osikowicz, 514-934-1934 ext. 31343, maria.osikowicz@mail.mcgill.ca
About this study
Official title: Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients: a Prospective, Longitudinal Study Employing Serum Cytokeratin 18 and Transient Elastography (Fibroscan)
The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to the new transplanted liver and it is often due to metabolic risk factors (including diabetes, rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the new liver). Some patients with fatty liver after liver transplant have non-alcoholic steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and loss of the transplanted liver. There has been no detailed study into the recurrence of NASH. One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan) and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much a liver is damaged and how much fat it contains without pain or complications. This is a year long study involving one screening visit and 3 study visits, 3 months apart.
Read the detailed description
This is a prospective, longitudinal, pilot study of non-invasive diagnostic tests to explore recurrent or de novo NAFLD/NASH in liver transplant recipients. The study will be conducted at the Royal Victoria Hospital, McGill University Health Centre (MUHC) Solid Organ Transplant Unit, which carries out 60 liver transplants per year. A dedicated liver transplant database is in place since 1990 and prospectively collects demographic and clinical characteristics of all patients. In November 2013, two fully equipped Fibroscan machines have been acquired by the Division of Gastroenterology and Hepatology of the MUHC. The MUHC is the first center in Quebec to have access to the latest modules of Fibroscan (CAP and XL probe) that are essential to diagnose hepatic steatosis. In preparation for the current project, the Investigators performed an analysis of frequencies of hepatitis C, alcoholic liver disease, NASH, hepatitis B as indications for liver transplantation MUHC Center Solid Organ Transplant in 2000 and 2013. NASH was the only indication that significantly increased (8% in 2000 vs 20% in 2013; p<0.0001) and currently represents the third indication.
Enrolled participants will be followed every 3 months for one year, in conjunction with their regular care visit.
Blood samples obtained during the screening and the study visits will be processed by the research technician of the MUHC Solid Organ Transplant Unit. The plasma will be stored at -80C until used for quantitative measurement of CK-18 levels by the Human cytokeratin ELISA kit.
The fibroscan examination will be performed on a 4-hour fasting participants. The standard M probe will be used in all participants. The XL probe will be used in obese patients (BMI>30 Kg/m2) and in case of failure of Fibroscan by the M probe. CAP examination will be performed at the same time to diagnose hepatic steatosis. A valid Fibroscan result will be defined by 10 validated measures and IQR < 30% of the median. Validated cut-off values will be applied to diagnose hepatic steatosis and fibrosis by Fibroscan/CAP. Grading of steatosis will be as following: mild steatosis (<30% of the hepatocytes); moderate steatosis (30-60%); severe steatosis (>60%).
- Conditions
- Non-alcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NASH in liver transplant recipients
CK-18 to indicate NASH
Measured: 18 months
Evaluation of liver steatosis in liver transplant recipients
Fibroscan with CAP to indicate steatosis
Measured: 18 months
Incidence of fibrosis
Liver stiffness measurement by Fibroscan
Measured: 18 months
Secondary outcomes (1)
Accuracy of noninvasive tests to diagnose NAFLD/NASH and hepatic fibrosis as compared to standard of care histology
Evaluate the accuracy of CK-18 and Fibroscan/CAP
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJul 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian National Transplant Research Program
- Responsible party
- Principal investigator, Giada Sebastiani, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Giada Sebastiani, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128918
- Sponsor's protocol ID
- 15-002-MUHC
- Status last verified
- Apr 2017
- First submitted
- 7 Aug 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients: a Prospective, Longitudinal Study Employing Serum Cytokeratin 18 and Transient Elastography (Fibroscan)
- ClinicalTrials.gov ID
- NCT03128918
- Acronym / sponsor ID
- 15-002-MUHC
- Conditions
- Non-alcoholic Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian National Transplant Research Program
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 25 Apr 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.
The purpose of this study is is to use non-invasive diagnostic tests, Fibroscan and a simple blood test, to diagnose NASH in patients who undergo liver transplantation. Liver transplantation is a life-saving procedure for people with cirrhosis. Fatty liver is a common reason for liver transplantation due to obesity and diabetes. Fatty liver can happen again to the new transplanted liver and it is often due to metabolic risk factors (including diabetes, rapid weight gain, and immunosuppressive therapy, which are used to avoid rejection of the new liver). Some patients with fatty liver after liver transplant have non-alcoholic steatohepatitis (NASH) injury to liver the tissue (inflammation) and damage which is caused by a build-up of fat in the liver. This is a serious problem and can lead to cirrhosis and loss of the transplanted liver. There has been no detailed study into the recurrence of NASH. One reason for this is one of the only ways to detect fatty liver and NASH is to have a liver biopsy, which can be painful and have complications. Recently, a new technology (Fibroscan) and a simple blood test (cytokeratin 18) have been developed which can tell doctors how much a liver is damaged and how much fat it contains without pain or complications. This is a year long study involving one screening visit and 3 study visits, 3 months apart.
Detailed description
This is a prospective, longitudinal, pilot study of non-invasive diagnostic tests to explore recurrent or de novo NAFLD/NASH in liver transplant recipients. The study will be conducted at the Royal Victoria Hospital, McGill University Health Centre (MUHC) Solid Organ Transplant Unit, which carries out 60 liver transplants per year. A dedicated liver transplant database is in place since 1990 and prospectively collects demographic and clinical characteristics of all patients. In November 2013, two fully equipped Fibroscan machines have been acquired by the Division of Gastroenterology and Hepatology of the MUHC. The MUHC is the first center in Quebec to have access to the latest modules of Fibroscan (CAP and XL probe) that are essential to diagnose hepatic steatosis. In preparation for the current project, the Investigators performed an analysis of frequencies of hepatitis C, alcoholic liver disease, NASH, hepatitis B as indications for liver transplantation MUHC Center Solid Organ Transplant in 2000 and 2013. NASH was the only indication that significantly increased (8% in 2000 vs 20% in 2013; p<0.0001) and currently represents the third indication.
Enrolled participants will be followed every 3 months for one year, in conjunction with their regular care visit.
Blood samples obtained during the screening and the study visits will be processed by the research technician of the MUHC Solid Organ Transplant Unit. The plasma will be stored at -80C until used for quantitative measurement of CK-18 levels by the Human cytokeratin ELISA kit.
The fibroscan examination will be performed on a 4-hour fasting participants. The standard M probe will be used in all participants. The XL probe will be used in obese patients (BMI>30 Kg/m2) and in case of failure of Fibroscan by the M probe. CAP examination will be performed at the same time to diagnose hepatic steatosis. A valid Fibroscan result will be defined by 10 validated measures and IQR < 30% of the median. Validated cut-off values will be applied to diagnose hepatic steatosis and fibrosis by Fibroscan/CAP. Grading of steatosis will be as following: mild steatosis (<30% of the hepatocytes); moderate steatosis (30-60%); severe steatosis (>60%).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post liver transplant
Key inclusion criteria (3 listed)
- Liver transplant recipient of any etiology;
- >18 years old;
- Able to provide informed consent.
Key exclusion criteria (2 listed)
- Liver transplant due to alcoholic liver disease as primary etiology;
- Liver transplant due to chronic hepatitis C, genotype 3.
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
Incidence of NASH in liver transplant recipients
Time frame: 18 months
CK-18 to indicate NASH
Evaluation of liver steatosis in liver transplant recipients
Time frame: 18 months
Fibroscan with CAP to indicate steatosis
Incidence of fibrosis
Time frame: 18 months
Liver stiffness measurement by Fibroscan
1 secondary outcome
Accuracy of noninvasive tests to diagnose NAFLD/NASH and hepatic fibrosis as compared to standard of care histology
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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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.
Giada Sebastiani principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Non-alcoholic Fatty Liver Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Osikowicz (514-934-1934 ext. 31343, maria.osikowicz@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of NASH in liver transplant recipients (time frame: 18 months). The study lists 3 primary outcomes in all. 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 25 Apr 2017.