Evaluation of Risk of hEpatocellular Carcinoma

NCT06523179 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Phase

Not applicable

Started

2018-01-01

Last updated

2025-11-20

Condition(s) studied

NASHHCCGenetic Predisposition

Investigational drug(s) / intervention(s)

quantify the impact of genetic risk factors

quantify the impact of genetic risk factors: the impact of genetic risk factors for the development of NAFLD-HCC and their interaction with acquired risk factors, on the incidence of the disease in a prospective cohort of patients at risk, through a score capable of predicting NAFLD-HCC and selecting patients for whom screening is cost-effective.

Study 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 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.

Eligibility

Sex

ALL

Min age

45 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction — up to 84 months
The different inclusion criteria are able to identify the number of individuals at risk for NAFLD-HCC among patients with NAFLD following up, Understand the impact of individual genetic variants on HCC risk and rates of patients hosting gene mutations in evolving fat accumulation in liver (global cohorts and according to enrolment criteria)
The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction — up to 84 months
The impact of genetic risk factors for NAFLD-HCC and their interaction will be realized by evaluating the interaction with risk factors and developing a score to predict NAFLD-HCC. These elements will enable us to select patients for whom screening can be effective.

Trial sites (1)

Facility	City	Region	Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica	Milan	Milano	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06523179 on ClinicalTrials.gov ↗ ← All trials in Italy