Colangioids to find genetic causes of atypical primary sclerosing cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Primary sclerosing cholangitis is a progressive bile-duct disease with no proven drug to halt progression, and this project uses colangioids and assembloids as in vitro models to explore genetic contributors. The study will collect samples from adults with confirmed atypical PSC, patients undergoing biopsy for suspected PSC, surgical liver resections, post-transplant biopsies, and cholecystectomies, and will include previously genotyped patients carrying ciliopathy-associated variants. Researchers will generate patient-derived colangioids/assembloids, perform genetic analyses, and test pharmacological responses in the lab to link specific variants to cellular behavior and drug sensitivity. Results are intended to identify genetic drivers and potential therapeutic targets to guide future personalized approaches.

Why it matters

Who can join: the full rules

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).

Where it's running

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Mi, Italy Recruiting

Study contacts

• Study coordinator: Luca Vittorio Carlo Valenti, Doctor
• Email: luca.valenti@policlinico.mi.it
• Phone: 02 5503 6595

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.