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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Istituto di Ricovero e Cura a Carattere Scientifico di natura pubblica
RECRUITING
Milan
Contact Information
Primary
Luca Vittorio Carlo Valenti
luca.valenti@policlinico.mi.it
02 5503 6595
Time Frame
Start Date: 2018-01-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 500
Treatments
Experimental: Risk factors for NAFLD-HCC
The study will be divided into:~* In the first phase, the impact of a score based on the evaluation of common genetic variants in genes predisposing to the development of NAFLD-HCC (PNPLA3, TM6SF2, and MBOAT7), and rare mutations determining high risk of NAFLD-HCC, e.g. . in genes involved in telomere shortening (TERT) and lipid metabolism (APOB) on the risk of developing HCC and on survival, in the entire cohort of patients and in the individual groups listed above.~* In the second phase we will use next generation sequencing techniques (whole exome / genome sequencing) to identify new genetic risk variants for the development of HCC.
Sponsors
Leads: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

This content was sourced from clinicaltrials.gov