Actively Recruiting
Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2026-03-24
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Primary sclerosing cholangitis (PSC) is a rare and progressive disease affecting the bile ducts, often leading to liver complications and cancer. This research focuses on atypical PSC (aPSC), exploring how genetic variants linked to ciliopathies, diseases affecting cell structures called cilia, may influence the severity and progression of PSC. The study aims to understand the role of these genetic factors and their impact on inflammation, fibrosis, and liver cancer development. The study uses three-dimensional cell cultures called assembloids, which mimic the structure and function of bile duct tissues more accurately than traditional models. These assembloids will be used to study the behavior of genetic variants involved in ciliopathies, including how they affect cholangiocyte cells, fibrosis activation, and immune cell infiltration. Researchers will also test new pharmacological approaches using extracellular vesicles containing the CRISPR/Cas9 genome editing system to potentially correct genetic mutations. Participants will be involved in providing tissue samples for generating assembloids to examine the cellular and molecular mechanisms of aPSC. Researchers will monitor the impact of genetic risk factors and pharmacological tests over 48 months. Outcomes include measuring the influence of genetic variants on PSC progression and evaluating the effects of drug tests on extracellular vesicles. The study is designed to improve precision medicine approaches for PSC by developing reliable in vitro models and assessing new treatments.
CONDITIONS
Brief Title
Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 90 years of age
- Of both sexes
- Willingness to sign informed consent for the study
- Patients with a confirmed atypical primary sclerosing cholangitis (aPSC) diagnosis
- Patients with suspected PSC who are candidates for liver biopsy
- Patients without aPSC listed for liver resection, post-transplant biopsy, or cholecystectomy
- Patients previously genotyped carrying gene variants associated with ciliopathies
You will not qualify if you...
- Positive for chronic viral hepatitis (HCV-RNA and HBsAg)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 48 months
Participants provide biological samples used to create three-dimensional assembloid models to study genetic factors and test pharmacological approaches related to atypical primary sclerosing cholangitis.
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122
Actively Recruiting
Research Team
L
Luca Vittorio Carlo Valenti, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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