RecruitingNot ApplicableNCT06523179

Evaluation of Risk of hEpatocellular Carcinoma

Study for the Evaluation of Risk of hEpatocellular Carcinoma in NonAlcoholic Fatty Liver


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

500 participants

Start Date

Jan 1, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is identifying people at higher risk of developing liver cancer (hepatocellular carcinoma, or HCC) among those with fatty liver disease or other liver conditions, to allow earlier detection and prevention. **You may be eligible if...** - You are between 45 and 75 years old - You have been diagnosed with non-alcoholic fatty liver disease (NAFLD) or unexplained liver disease (with a moderate alcohol component acceptable) - You have significant liver scarring (F3–F4 fibrosis or cirrhosis), confirmed by biopsy or non-invasive tests - OR you have a family history of liver cancer in a first-degree relative, or carry certain genetic risk mutations - OR you are a male with type 2 diabetes or obesity AND carry at least 3 specific genetic risk variants - You are willing to sign informed consent **You may NOT be eligible if...** - You drink more than 60 g/day of alcohol (men) or 40 g/day (women) - You have chronic viral hepatitis (B or C) or autoimmune hepatitis - You have a known genetic liver disease (e.g., hemochromatosis, Wilson's disease) - You take medications known to cause liver disease - You have already been diagnosed with liver cancer - You have another serious condition with a life expectancy of less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERquantify 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.


Locations(1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica

Milan, Milano, Italy

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NCT06523179


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