Evaluating the risk of liver cancer in patients with fatty liver disease
Study for the Evaluation of Risk of hEpatocellular Carcinoma in NonAlcoholic Fatty Liver
This study is testing how fatty liver disease might lead to liver cancer by looking at genetic and metabolic factors in patients with this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06523179 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 45 to 75 with a diagnosis of NAFLD or cryptogenic liver disease and specific genetic risk factors.
Not a fit: Patients with excessive alcohol intake or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and targeted prevention strategies for liver cancer in at-risk populations.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a link between NAFLD and HCC, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Milano
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.