How genes and alcohol interact to affect liver cancer risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project will combine genetic testing and detailed clinical data from the existing EPIDEMIC and SERENA cohorts to measure how inherited variants and environmental exposures interact in alcohol-related hepatocellular carcinoma (HCC). Eligible participants include people with NAFLD or cryptogenic liver disease, with a focused subgroup of men who have type 2 diabetes or obesity and carry multiple risk variants in PNPLA3, TM6SF2, and MBOAT7. Investigators will quantify alcohol intake, metabolic risk factors, and genetic profiles and correlate these with HCC occurrence to model gene–environment risk. The work is performed at a single center in Milan using previously approved cohort frameworks and new genetic analyses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
  Milan, Milano, Italy Recruiting

Study contacts

• Study coordinator: Serena Pelusi
• Email: serena.pelusi@policlinico.mi.it
• Phone: 02 5503 4192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.