RecruitingNot ApplicableNCT07272200

Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

1,000 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

It has been estimated that alcohol causes around 40% of premature liver deaths in Europe each year, although this number is probably underestimated. Alcohol-related liver disease (ALD) is the most common cause of liver cirrhosis and liver death in Europe with a peak age of deaths occurring among individuals aged 40 to 50. Despite these findings, ALD is little studied with only 5% of all clinical trials in the field of liver disease recorded on ClinicalTrials.gov and only 5% of all publications in the same research area. Liver cancer is the second most common cause of cancer-related death (15-20% survival at 5 years) and the second most common cause of alcohol-related cancers worldwide. Like other complex diseases, ALD-HCC results from the interaction between environmental determinants and genetic variations but knowledge of gene-environment interactions is currently lacking in this area. The GENIAL project will address these needs through a comprehensive evaluation of gene-environment interactions concerning ALD-HCC.


Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how genes and alcohol use together influence the development of liver cancer in people who have fatty liver disease or liver disease linked to alcohol. By studying stored samples from patients already enrolled in prior approved studies, researchers hope to find genetic markers that increase risk. **You may be eligible if...** - You were previously enrolled in the EPIDEMIC or SERENA studies at a participating Italian center - You have non-alcoholic fatty liver disease (NAFLD), cryptogenic liver disease, or liver disease with a moderate alcohol component - You carry certain genetic variants associated with liver disease risk (if male with type 2 diabetes or obesity) **You may NOT be eligible if...** - You were not previously enrolled in the linked studies - You do not have the relevant liver condition - You have not provided prior consent for sample use 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

OTHERquantify of risk factors

the impact of risk factors and their interaction on the incidence of disease through a score that predicts HCC and select patients for whom screening is convenient.


Locations(1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, Italy

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NCT07272200


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