Actively Recruiting
Evaluation of Risk of hEpatocellular Carcinoma
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-11-20
500
Participants Needed
1
Research Sites
939 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Evaluation of Risk of hEpatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of NAFLD or cryptogenic liver disease with alcohol intake less than 60 g/day for men and 40 g/day for women
- Age between 45 and 75 years
- Presence of F3-F4 fibrosis confirmed by histology or non-invasive tests (Fibroscan stiffness > 7.9 kPa plus positive NAFLD fibrosis score, APRI, or FIB4), or evidence of cirrhosis by lab or imaging
- Family history of primary liver cancer in first-degree relatives or carrier of rare mutations linked to HCC (e.g., APOB, TERT)
- Male patients with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, and MBOAT7
- Willingness to sign informed consent
You will not qualify if you...
- Alcohol intake greater than 60 g/day for men or 40 g/day for women
- Chronic viral or autoimmune hepatitis
- Previously diagnosed genetic liver diseases associated with higher HCC risk (e.g., hereditary hemochromatosis, Wilson's disease, Alpha-1 Antitrypsin deficiency)
- Use of drugs known to cause steatosis and liver disease
- Diagnosis of HCC before study start
- Other medical conditions with life expectancy less than two years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
Milan, Milano, Italy, 20122
Actively Recruiting
Research Team
L
Luca Vittorio Carlo Valenti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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