Actively Recruiting
Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-12-09
1000
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients from the EPIDEMIC and SERENA studies approved by CE Milano Area 2
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) or cryptogenic liver disease, allowing alcohol intake less than 60 g/day for males and less than 40 g/day for females
- Male patients with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7
- Willingness to sign informed consent
You will not qualify if you...
- Alcohol intake greater than 60 g/day for males or greater than 40 g/day for females
- Chronic viral or autoimmune hepatitis
- Previously diagnosed liver genetic diseases linked to increased risk of liver cancer (e.g., hereditary hemochromatosis, Wilson's disease, Alpha-1 antitrypsin deficiency)
- Use of drugs that cause liver disease or fat accumulation in the liver
- Liver cancer diagnosis before the study starts
- Other serious illnesses with life expectancy less than two years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Milano, Italy, 20122
Actively Recruiting
Research Team
S
Serena Pelusi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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