- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128918
Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients
Non-invasive Diagnosis of Non-alcoholic Steatohepatitis in Liver Transplant Recipients: a Prospective, Longitudinal Study Employing Serum Cytokeratin 18 and Transient Elastography (Fibroscan)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Maria Osikowicz
- Phone Number: 31343 514-934-1934
- Email: maria.osikowicz@mail.mcgill.ca
Study Locations
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Recruiting
- McGill University Health Center
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Contact:
- Maria Osikowicz
- Phone Number: 31343 514-934-1934
- Email: maria.osikowicz@mail.mcgill.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Liver transplant recipient of any etiology;
- >18 years old;
- Able to provide informed consent.
Exclusion Criteria:
- Liver transplant due to alcoholic liver disease as primary etiology;
- Liver transplant due to chronic hepatitis C, genotype 3.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of NASH in liver transplant recipients
Time Frame: 18 months
|
CK-18 to indicate NASH
|
18 months
|
Evaluation of liver steatosis in liver transplant recipients
Time Frame: 18 months
|
Fibroscan with CAP to indicate steatosis
|
18 months
|
Incidence of fibrosis
Time Frame: 18 months
|
Liver stiffness measurement by Fibroscan
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of noninvasive tests to diagnose NAFLD/NASH and hepatic fibrosis as compared to standard of care histology
Time Frame: 18 months
|
Evaluate the accuracy of CK-18 and Fibroscan/CAP
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-002-MUHC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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