Actively Recruiting
Study for the Evaluation of Risk of Hepatocellular Carcinoma in Non-Alcoholic Fatty Liver Disease
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2025-11-20
500
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the risk factors for hepatocellular carcinoma (HCC), a common and deadly liver cancer, especially related to nonalcoholic fatty liver disease (NAFLD). NAFLD is caused mainly by insulin resistance from unhealthy lifestyles and is becoming a leading cause of HCC. This study aims to understand the genetic and acquired factors that contribute to NAFLD-related liver cancer, including how obesity, diabetes, and genetic mutations promote cancer development. The research involves evaluating genetic variants that increase the risk of NAFLD-HCC, including common mutations in genes like PNPLA3, TM6SF2, and MBOAT7, as well as rare mutations in genes related to telomere shortening and lipid metabolism such as TERT and APOB. The study is conducted in two phases: first, assessing the impact of these genetic risk factors and their interactions on HCC risk and survival; second, using advanced sequencing technologies to discover new genetic variants associated with HCC. Participants diagnosed with NAFLD or cryptogenic liver disease, aged 45 to 75 years, will be involved. They will undergo genetic testing and evaluations of liver health through biopsies or non-invasive measures like Fibroscan and blood tests. Researchers will monitor the influence of genetic and family history factors on liver cancer risk over up to 84 months. The study also excludes individuals with significant alcohol use, other liver diseases, or prior liver cancer diagnosis.
CONDITIONS
Brief Title
Evaluation of Risk of hEpatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of nonalcoholic fatty liver disease or cryptogenic liver disease with alcohol intake less than 60 g/day for males and 40 g/day for females
- Age between 45 and 75 years
- Presence of advanced liver fibrosis (F3-F4) or cirrhosis confirmed by biopsy, Fibroscan, or blood tests
- Family history of primary liver cancer in a first-degree relative, or carrier of rare mutations linked to liver cancer risk (e.g., APOB, TERT)
- Male 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 exceeding 60 g/day for males or 40 g/day for females
- Chronic viral hepatitis or autoimmune hepatitis
- Diagnosed genetic liver diseases associated with liver cancer risk, such as hereditary hemochromatosis, Wilson's disease, or Alpha-1 Antitrypsin deficiency
- Use of drugs that cause liver fat accumulation or liver disease
- Diagnosis of liver cancer before the study start date
- Other serious health conditions expected to limit survival to less than two years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 84 months
Participants are observed to evaluate the impact of genetic risk factors and their interaction with acquired factors on the development of NAFLD-HCC over time.
Periodic assessments according to study protocol
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
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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