Screening for liver fibrosis in at-risk populations using non-invasive methods
Screening At-risk Populations for Hepatic Fibrosis With Non-invasive Markers
This study is testing non-invasive methods to check for advanced liver damage in people at risk, like those with a history of heavy drinking or metabolic syndrome, to see how well these methods work compared to traditional tests.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6500 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT03308916 on ClinicalTrials.gov |
What this trial studies
This study aims to screen at-risk populations for advanced liver fibrosis using transient elastography and other non-invasive serum and imaging markers. Conducted at Odense University Hospital, it will involve 3000 participants from at-risk groups, such as those with a history of alcohol overuse or metabolic syndrome, and 3500 participants from the general population. The study will evaluate the effectiveness of these screening tools in detecting advanced fibrosis and compare novel serum markers against transient elastography. Participants with elevated liver stiffness will undergo further investigations, including elastography and liver biopsy, to confirm fibrosis status.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 30-75 with a history of significant alcohol consumption or metabolic syndrome.
Not a fit: Patients without risk factors for liver disease or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and management of liver fibrosis, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using non-invasive markers for liver fibrosis detection, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA Patients are eligible for screening if the following inclusion criteria are fulfilled: * Age 30-75 years (except the general population, which should be aged 40-75) * Informed consent to study investigations * Ability to read and write Danish AND (only at-risk patients) * Prior or current alcohol overuse, defined as an average intake of ≥24 grams/day (14 units/week) for women and ≥36 grams/day (21 units/week) for men, for at least 5 years; OR * Presence of the metabolic syndrome defined by central obesity plus any two of the following four metabolic risk factors: (a) raised triglycerides, (b) reduced HDL cholesterol, (c) raised blood pressure and (d) raised fasting plasma glucose;\[38\] OR * Type 2 diabetes mellitus defined by either fasting plasma glucose ≥7 mmol/L, HbA1c ≥48 mmol/mol, a random plasma glucose ≥11.1 mmol/L in the presence of classic diabetes or an oral glucose tolerance test with fasting plasma glucose ≥7.0 mmol/L and/or 2 hour plasma glucose ≥11.1 mmol/L. EXCLUSION CRITERIA We will exclude patients from screening in case of: * Evidence of decompensated liver disease, defined by clinically obvious ascites, overt hepatic encephalopathy, jaundice or large esophageal varices with/without variceal bleeding. * Known concurrent liver disease other than ALD and NAFLD. * Cancer or other debilitating disease with an expected survival of less than 12 months. * Inability to comply with the study protocol. In screened patients with liver stiffness ≥8 kPa we will abstain from a liver biopsy in case of: * Contraindications for a percutaneous liver biopsy * Severe alcoholic hepatitis or other hepatic inflammation evidenced by transaminase elevation of more than three times the upper limit of normal. * Hepatic congestion or bile duct dilation evidenced by ultrasound. * Decrease of TE below 6.0 kPa from screening to time of planned liver biopsy.
Where this trial is running
Odense
- Department of Gastroenterology and Hepatology, Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Maja Thiele, MD, PhD, Professor — Department of Gastroenterology and Hepatology, Odense University Hospital
- Study coordinator: Maja Thiele, MD, PhD, Professor
- Email: maja.thiele@rsyd.dk
- Phone: +4524998068
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.