Evaluating the risk of liver cancer in patients with fatty liver disease

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

This study aims to investigate the mechanisms linking nonalcoholic fatty liver disease (NAFLD) to the progression of hepatocellular carcinoma (HCC). It focuses on understanding how genetic predisposition and metabolic factors contribute to the development of HCC in individuals with NAFLD. The study will quantify the impact of genetic risk factors and assess the role of chronic inflammation and insulin resistance in promoting liver cancer. Participants will undergo evaluations to determine their eligibility based on specific criteria related to liver health and genetic markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\<60/40 g/day in M/F), so as to also include subjects with a moderate alcoholic component of liver disease, an important factor given the high epidemiological burden of this group
* Age between 45 and 75 years
* Any of the following criteria:
* F3-F4 fibrosis, determined histologically, or by non-invasive techniques (stiffness \> 7.9 kPa at Fibroscan and positivity at the NAFLD fibrosis score or at APRI or at FIB4), or evidence of cirrhosis deriving from biochemical tests or imaging methods;
* Family history of primary liver cancer in first degree parentage, or carrier status of rare mutations associated with the development of HCC (such as mutations in APOB and TERT)
* Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7.
* Willingness to sign the informed consent.

Exclusion Criteria:

* Alcohol intake \>60/40 g/day in M/F
* Chronic viral or autoimmune hepatitis
* Any previously diagnosed genetic liver 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 diagnosed before the study start date.
* Other pathological conditions with a prognosis of 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: Luca Vittorio Carlo Valenti
• Email: luca.valenti@policlinico.mi.it
• Phone: 02 5503 6595

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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.