RecruitingNCT06098417

Biomarkers in the Diagnosis and Prognosis of NAFLD

Identification of New Biomarkers in the Diagnosis and Prognosis of Non-alcoholic Fatty Liver Disease and Correlation With Ultrasound and Elastographic Findings


Sponsor

University of Trieste

Enrollment

500 participants

Start Date

Sep 22, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

Fibrosis is considered the leading cause of liver diseases and related mortality. Specifically, hepatic fibrosis is regarded as the consequence of reparative mechanisms initiated by hepatocytes in response to chronic damage. In Western countries, the main known etiologies include hepatitis (B and C), alcoholism, and non-alcoholic steatohepatitis (NASH). In particular, obesity is a determining factor in the onset and development of NASH. Alarming statistical data indicate that over 30% of the world's population is obese, and this eating disorder is increasingly affecting young people. NASH is a chronic disease that can present different degrees of fibrosis and, as the final stage, lead to the development of liver cirrhosis. Currently, the only accurate diagnostic and assessment system for this condition is liver biopsy, as there are no accurate non-invasive clinical tests available. The aim of this project is to identify (in silico) potential biomarkers involved in the development and progression of hepatic fibrosis and validate their presence and quantity in serum or plasma samples from obese patients (at-risk population). This would avoid the need for a liver biopsy and allow "at-risk" patients to undergo a simple ambulatory blood draw. Additionally, performing elastometry of the liver would allow for comparison of radiological results with laboratory findings.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for markers in the blood and tissue that can help diagnose and predict outcomes for people with fatty liver disease (NAFLD — non-alcoholic fatty liver disease) who are having weight-loss surgery. Researchers want to identify better ways to detect how serious someone's liver disease is without always needing an invasive procedure. **You may be eligible if...** - You have a BMI greater than 35 (classified as severe obesity) - You are already scheduled and eligible for bariatric (weight-loss) surgery according to international guidelines **You may NOT be eligible if...** - You have an active viral liver infection (such as hepatitis) - You have a history of alcohol or drug addiction - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma Test

IGF-2 (insulin-like growth factor 2)

DIAGNOSTIC_TESTPlasma test

SPARC (secreted protein acidic and rich in cysteine)

DIAGNOSTIC_TESTPlasma test

EPICAN (heparan sulfate proteoglycan)

DIAGNOSTIC_TESTPlasma test

EGFR (epidermal growth factor receptor)

DIAGNOSTIC_TESTLiver biopsy

Fibrosis and steatosis grade according to Brunt-Kleiner classification

DIAGNOSTIC_TESTVisceral adipose tissue biopsy

Presence of inflammation

DIAGNOSTIC_TESTLiver elastography

Grade of fibrosis according to Hamaguchi score

DIAGNOSTIC_TESTBlood test

Determination of surrogate based diagnostic tests/scores for liver fibrosis


Locations(1)

Silvia Palmisano

Trieste, Italy

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NCT06098417


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