Actively Recruiting
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Led by Maja Thiele · Updated on 2022-09-01
6500
Participants Needed
1
Research Sites
942 weeks
Total Duration
On this page
Sponsors
M
Maja Thiele
Lead Sponsor
H
Horizon 2020 - European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Prospective screening study at Odense University Hospital to assess the effect of transient elastography and other serum and imaging markers of liver fibrosis to detect advanced fibrosis (Kleiner Fibrosis score F3-F4) in patients at risk of non-alcoholic fatty liver disease, alcoholic fatty liver disease, with a control group of participants recruited from the general population.
CONDITIONS
Official Title
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 30 to 75 years for at-risk patients; 40 to 75 years for general population participants
- Ability to give informed consent
- Ability to read and write Danish (for at-risk patients only)
- Prior or current alcohol overuse, defined as at least 14 units per week for women and 21 units per week for men, for more than 5 years
- Presence of metabolic syndrome defined by central obesity plus any two of these: high triglycerides, low HDL cholesterol, high blood pressure, or high fasting plasma glucose
- Diagnosis of type 2 diabetes mellitus defined by fasting plasma glucose, HbA1c, random glucose, or oral glucose tolerance test values according to specified thresholds
You will not qualify if you...
- Evidence of decompensated liver disease such as ascites, hepatic encephalopathy, jaundice, or large esophageal varices
- Known liver diseases other than alcoholic or non-alcoholic fatty liver disease
- Cancer or other serious illness with expected survival less than 12 months
- Inability to comply with study protocol
- Contraindications to liver biopsy
- Severe alcoholic hepatitis or liver inflammation with transaminase levels more than three times normal
- Liver congestion or bile duct dilation seen on ultrasound
- Decrease of transient elastography below 6.0 kPa between screening and planned biopsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Gastroenterology and Hepatology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
M
Maja Thiele, MD, PhD, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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