Evaluation of Risk of hEpatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
quantify the impact of genetic risk factors
Other interventionthe 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Risk factors for NAFLD-HCCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction
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)
Time frame
up to 84 months2
The quantify the impact of genetic risk factors for NAFLD-HCC and their interaction
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.
Time frame
up to 84 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov