Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis
Not applicable · Testing Use of assembloids as in vitro models to test new pharmacological approaches · 1 site · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Use of assembloids as in vitro models to test new pharmacological approaches. Condition(s) listed: PSC.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 90
- Any sex
Some of the main requirements, copied from the record:
- 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:
Plus 4 more requirement(s). There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 80 participants are expected to take part.
- The study has 1 group.
- Start date: 2024-12-01.
- Main results expected around 2026-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Italy.
Groups in this study
- Behaviour of the genetic variants involved in ciliopathies. (listed as: experimental group)
Main thing being measured
- The quantify the impact of genetic risk factors for PSC and the role genetic variants (48 months)
In the researchers’ words
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…
Words you might see
- Cirrhosis: advanced scarring of the liver.
- Cholangiocarcinoma: cancer of the bile ducts.
- Cholestasis: reduced or blocked flow of bile.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | PSC |
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Enrollment | 80 (estimated) |
| Start date | 2024-12-01 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-03-10 |
| Last updated | 2026-03-24 |
| Official title | Colangioids to Define the Genetic Factors Involved in Atypical Primary Sclerosing Cholangitis |
| ClinicalTrials.gov ID | NCT06865924 |
Interventions
- Use of assembloids as in vitro models to test new pharmacological approaches (Other)
Using extracellular vesicles containing the CRISPR/Cas9 genome editing system that by faithfully reproducing the in vivo part will allow a more faithful response than the use of conventional 2D model, organoids or animal model.
Full eligibility criteria (from the record)
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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan, MI | Italy | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.