Evaluation of Risk of hEpatocellular Carcinoma
Recruiting · NCT06523179 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Hepatocellular carcinoma (HCC) is the fifth most common solid cancer and the second cause of cancer-related mortality worldwide. Nonalcoholic fatty liver disease (NAFLD), that is hepatic accumulation of fat in excess of 5% not explained by at risk alcohol intake, is projected to become the leading cause of HCC in Western countries within 2025.NAFLD is most frequently caused by insulin resistance due to unhealthy lifestyle. Due to the epidemics of obesity and type 2 diabetes, NAFLD now affects one in three individuals worldwide. NAFLD-HCC frequently develops without overt cirrhosis suggesting that steatosis directly promotes hepatic carcinogenesis.
Who can take part
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 is running
1 location listed.
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica - Milan, Milano, Italy