NCT07272200 Understanding Gene ENvironment Interaction in ALcohol-related Hepatocellular Carcinoma
| NCT ID | NCT07272200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | HCC |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07272200 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying HCC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07272200 currently recruiting?
Yes, NCT07272200 is actively recruiting participants. Contact the research team at serena.pelusi@policlinico.mi.it for enrollment information.
Where is the NCT07272200 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07272200 clinical trial?
NCT07272200 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The trial plans to enroll 1,000 participants.