NCT06777914Recruiting
Familial Intrahepatic Cholestasis-related Genes Associated with Disease Susceptibility in Hepato-biliary Cancers
Source: ClinicalTrials.gov · Last updated 16 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 3 Dec 2024
- Start date
- 22 Oct 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- NCT number
- NCT06777914
What you commit to
- Study type: Observational
- Planned participants: 600
- From 22 Oct 2024 to the primary completion date, Oct 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 12 months to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Chirurgia Epatobiliare e dei Trapianti Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna per il trattamento delle gravi insufficienze d'organo Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Medicina Interna, malattie epatobiliari e immunoallergologiche Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - Programma Chirurgia addominale nell'insufficienza d'organo terminale e nei pazienti con trapianto d'organo Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna - UO Gastroenterologia Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.