NCT06777914 Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers
| NCT ID | NCT06777914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Hepatobiliary Cancers |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-10-22 with a primary completion date of 2027-10.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. GGT and/or alkaline phosphatase \>1.5 times the normal values in two or more measurements taken at least 6 months apart, 2. A history of pruritus combined with \[BA\] \>10 mmol/l for a period of ≥6 months. * Obtaining written informed consent Exclusion Criteria: * 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
Contact & Investigator
Giovanni Vitale, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06777914 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, studying Hepatobiliary Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06777914 currently recruiting?
Yes, NCT06777914 is actively recruiting participants. Contact the research team at giovanni.vitale@aosp.bo.it for enrollment information.
Where is the NCT06777914 trial being conducted?
This trial is being conducted at Bologna, Italy, Bologna, Italy, Bologna, Italy, Bologna, Italy and 1 additional location.
Who is sponsoring the NCT06777914 clinical trial?
NCT06777914 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Giovanni Vitale, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 600 participants.
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