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Clinical Trials in Italy / NCT07272200
Recruiting Not applicable

Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma

NCT07272200 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase
Not applicable
Started
2023-12-01
Last updated
2025-12-09

Condition(s) studied

HCCGenetic Predisposition

Investigational drug(s) / intervention(s)

quantify of risk factors

quantify of risk factors: the impact of risk factors and their interaction on the incidence of disease through a score that predicts HCC and select patients for whom screening is convenient.

Study summary

It has been estimated that alcohol causes around 40% of premature liver deaths in Europe each year, although this number is probably underestimated. Alcohol-related liver disease (ALD) is the most common cause of liver cirrhosis and liver death in Europe with a peak age of deaths occurring among individuals aged 40 to 50. Despite these findings, ALD is little studied with only 5% of all clinical trials in the field of liver disease recorded on ClinicalTrials.gov and only 5% of all publications in the same research area.

Liver cancer is the second most common cause of cancer-related death (15-20% survival at 5 years) and the second most common cause of alcohol-related cancers worldwide.

Like other complex diseases, ALD-HCC results from the interaction between environmental determinants and genetic variations but knowledge of gene-environment interactions is currently lacking in this area. The GENIAL project will address these needs through a comprehensive evaluation of gene-environment interactions concerning ALD-HCC.

Eligibility

Sex
ALL
Min age
45 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Patients from the EPIDEMIC (approval no. 1822 of 27 August 2013) and SERENA (last amendment no. 1151\_2021 of 9 November 2021), already approved by the CE Milano Area 2 will be included. * Diagnosis of NAFLD or cryptogenic liver disease, allowing a more liberal alcohol intake limit (\<60/40 g/day in M/F), so that subjects with a moderate alcoholic component of the hepatopathy are also included, Important factor given the high epidemiological weight of this group * Any of the following: * Male patient with type 2 diabetes or obesity carrying at least three genetic variants in PNPLA3, TM6SF2, MBOAT7. * Willingness to sign informed consent. Exclusion Criteria: * Alcohol intake \>60/40 g/day in M/F * Chronic viral or autoimmune hepatitis * Any previously diagnosed liver genetic 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 previously diagnosed the study start date. * Other pathological conditions with prognosis less than two years.

Primary outcome measure(s)

  • Impact of genetic risk factors — up to 60 months
    The research aims to conduct the Measurement of the Frequency/Incidence (expressed as the percentage of the study population) of new genetic variants, identified using DNA Sequencing and subsequent bioinformatics analysis, that are associated with HCC in patients with ALD and related NAFLD. This measurement will be followed by the assessment of the CORRELATION between the newly identified genetic variants and the Prevalence (expressed as the percentage of the general population) of the clinical phenotype ALD-HCC.

Trial sites (1)

FacilityCityRegionStatus
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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Other trials for the same condition

Evaluation of Risk of hEpatocellular Carcinoma Recruiting
Accumulation of Lipid Droplets as an Underlying Cause of the Progression of Fatty Liver Disease to Liver Cancer Active, not recruiting
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED) Recruiting
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Pancreatic Cancer Early Detection Consortium Recruiting
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 NCT07272200 on ClinicalTrials.gov ↗ ← All trials in Italy