Actively Recruiting

Age: 12Months +
All Genders
NCT06777914

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-16

600

Participants Needed

5

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of primary liver or biliary tumors (hepatocellular carcinoma, cholangiocarcinoma, hepatocholangiocarcinoma) without obvious chronic liver disease or in cryptogenic chronic liver disease
  • Curative treatment by surgical tumor removal or liver transplantation
  • Cholestatic chronic liver disease with GGT and/or alkaline phosphatase over 1.5 times normal in two or more tests at least 6 months apart
  • History of itching combined with bile acid levels over 10 mmol/l for 6 months or longer
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Other documented chronic liver diseases explaining the symptoms, including primary biliary cholangitis, primary sclerosing cholangitis, IgG4-related cholangiopathy
  • Obstructive jaundice excluded by normal bile duct anatomy
  • Negative tests for hepatitis B, C, and E viruses
  • History of alcohol abuse
  • Diagnosed hemochromatosis, Wilson's disease, or alpha-1 antitrypsin deficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Programma Chirurgia addominale nell'insufficienza d'organo terminale e nei pazienti con trapianto d'organo

Bologna, Bologna, Italy, 40138

Actively Recruiting

2

IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Chirurgia Epatobiliare e dei Trapianti

Bologna, Bologna, Italy, 40138

Actively Recruiting

3

IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Gastroenterologia

Bologna, Bologna, Italy, 40138

Actively Recruiting

4

IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna per il trattamento delle gravi insufficienze d'organo

Bologna, Bologna, Italy, 40138

Actively Recruiting

5

IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna, malattie epatobiliari e immunoallergologiche

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Giovanni Vitale

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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