Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers

Recruiting now

Conditions studied: Hepatobiliary Cancers, Progressive Familial Intrahepatic Cholestasis (PFIC), Cholestatic Liver Disease

In brief

This is a cross-sectional, multicenter tissue study with an exploratory aim to estimate the prevalence of genetic mutations that predispose individuals to diseases in the context of cholestatic disorders and hepatobiliary neoplasms. It is intended as a hypothesis-generating study for future empirical investigations.

Key facts

Study ID

NCT06777914

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

600

Starts

2024-10-22

Expected to finish

2027-10-01

Last updated by the study team

2025-01-16

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Instrumental or histological diagnosis of HBCs, defined as primary liver and/or biliary tumors (hepatocellular carcinoma, cholangiocarcinoma, hepatocholangiocarcinoma) occurring in patients without apparent underlying chronic liver disease or in the context of cryptogenic chronic liver disease;
• Curative treatment through surgical resection of the neoplasm or liver transplantation
• Diagnosis of CCLDs defined as:
• GGT and/or alkaline phosphatase >1.5 times the normal values in two or more measurements taken at least 6 months apart,
• A history of pruritus combined with [BA] >10 mmol/l for a period of ≥6 months.
• Obtaining written informed consent

You may not qualify if…

• Other documented causes of chronic liver disease that can justify the clinical phenotype include:
• Primary biliary cholangitis Primary sclerosing cholangitis IgG4-related cholangiopathy Obstructive jaundice excluded by the demonstration of normal bile duct anatomy Negative virological tests for HBV, HCV, HEV Alcohol abuse Hemochromatosis Wilson's disease Alpha-1 antitrypsin deficiency

Where it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna - Programma Chirurgia addominale nell'insufficienza d'organo terminale e nei pazienti con trapianto d'organo — Bologna, Bologna, Italy (enrolling)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Chirurgia Epatobiliare e dei Trapianti — Bologna, Bologna, Italy (enrolling)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Gastroenterologia — Bologna, Bologna, Italy (enrolling)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna per il trattamento delle gravi insufficienze d'organo — Bologna, Bologna, Italy (enrolling)
• IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna, malattie epatobiliari e immunoallergologiche — Bologna, Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.