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Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis

RecruitingNAAges 18 Years - 90 YearsAllFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT06865924 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Primary sclerosing cholangitis (PSC) is a rare, progressive and often fatal disease of the intrahepatic or extrahepatic bile ducts, with an estimated prevalence in Western countries of 1/10,000. Biliary disease in PSC is represented by cholestasis, chronic inflammation of the bile ducts, the small tubes through which bile passes, progressive concentric fibrosis around the bile ducts2. This results in an obstruction to the passage of bile, which can lead to the development of cirrhosis with complications related to portal hypertension, cholangitis and often progress to bile duct cancer (cholangiocarcinoma). The only curative therapy in patients with PSC is liver transplantation, since no drug has been shown to be effective in preventing disease progression. The etiology is most likely multifactorial immune-mediated, where the onset of PSC is triggered by environmental factors in a genetic

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📋 Eligibility rules (as published)
Inclusion Criteria: * Between 18 and 90 years of age * Of both sexes * willingness to sign informed consent for the study; Additional criteria group 1 * Patients with a confirmed aPSC diagnosis Additional criteria group 2 * patients with suspected PSC liver biopsy candidates Additional criteria group 3 * Patients not affected by aPSC listed for the following procedures: * Liver resection for hepatocellular or other hepatic lesions (including secondary effects from other cancers and benign focal lesions, which will result in healthy liver tissue); * Post-transplant biopsies of healthy liver; * cholecystectomies. Additional criteria group 4 * Patients previously genotyped in the study "Impact of complete exoma sequencing on clinical management of patient with non-alcoholic liver steatosis and cryptogenic liver disease project code RF-2016-02364358" results carrying gene variants associated with ciliopathies Exclusion Criteria: -Positive for chronic viral hepatitis (HCV-RNA and HBsAg).
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What it tests

  • Use of assembloids as in vitro models to test new pharmacological approaches
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Where

1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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