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Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma

RecruitingNAAges 45 Years - 75 YearsAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT07272200 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 are

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📋 Eligibility rules (as published)
Inclusion Criteria: Patients from the EPIDEMIC (approval no. 1822 of 27 August 2013) and SERENA (last amendment no. 1151\_2021 of 9 November 2021), already approved by the CE Milano Area 2 will be included. * Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\<60/40 g/day in M/F), so that subjects with a moderate alcoholic component of the hepatopathy are also included, Important factor given the high epidemiological weight of this group * Any of the following: * Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7. * Willingness to sign informed consent. Exclusion Criteria: * Alcohol intake \>60/40 g/day in M/F * Chronic viral or autoimmune hepatitis * Any previously diagnosed liver genetic disease associated with increased risk of HCC (such as hereditary hemochromatosis, Wilson's disease, Alpha-1 antitrypsin deficiency) * Use of drugs known to induce steatosis and liver disease * HCC previously diagnosed the study start date. * Other pathological conditions with prognosis less than two years.
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What it tests

  • quantify of risk factors
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Where

1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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