Gene and Alcohol Interaction in Liver Cancer Study
Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma
Recruiting
N/AInterventional Study
HCCGenetic Predisposition
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,000 (estimated)
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Other
Who this trial is looking for
This trial is looking for patients with liver disease related to alcohol use. Participants must agree to sign a consent form and will be evaluated for genetic factors affecting liver health.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with NAFLD or cryptogenic liver disease
I am male and have type 2 diabetes or obesity with certain genetic traits
I drink alcohol within the limit of 60 grams per day
I am willing to sign informed consent
You may not be able to join if
I drink more than 60 grams of alcohol per day
I have chronic viral hepatitis
I have an autoimmune hepatitis
I have a previously diagnosed liver genetic disease linked to liver cancer risk
I use drugs that cause liver disease
I have been diagnosed with liver cancer before the study starts
I have another health condition that could limit my life to under two years
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 t…
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.
Trial Locations
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Eligibility Criteria
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 l…
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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