Status:
RECRUITING
Evaluation of Risk of hEpatocellular Carcinoma
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
NASH
HCC
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The mechanisms linking NAFLD to liver disease progression towards HCC have not yet been identified. Anyhow several pathways may be activated in obesity and diabetes favoring a tumor-promoting environm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06523179
Start Date
January 1 2018
End Date
December 31 2035
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Milano, Italy, 20122