National database for patients with primary sclerosing cholangitis
Official title: Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patient's Database Linked to a Biological Sample Storage
Run by University of Milano Bicocca · NCT05618145 · Data updated 2026-11-12
This study is creating a national database for people in Italy with primary sclerosing cholangitis to gather important health information and improve understanding of the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 17 Years and up |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 63 sites (Ancona and 62 other locations) |
| Status | Recruiting |
| Started | October 21, 2022 |
| Main results expected | October 21, 2032 |
| Study ends | October 21, 2032 |
| Registry record updated | January 2, 2024 |
| Trial ID | NCT05618145 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with primary sclerosing cholangitis who are willing to provide informed consent.
✕Probably not a fit
Patients who do not have a diagnosis of primary sclerosing cholangitis or are unwilling to participate in the study will not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a national database for patients diagnosed with primary sclerosing cholangitis (PSC) in Italy, a rare and chronic liver disease. The study will collect clinical information and link it to a biological sample storage to better understand the disease's epidemiology and impact. PSC is associated with significant health risks, including liver failure and cancer, and the database will help in assessing the true burden of the disease in the Italian population. By gathering comprehensive data, the study seeks to improve patient outcomes and inform future research.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the epidemiology of PSC, leading to improved management and treatment strategies for patients.
How similar studies have gone: While there is limited data on PSC in Italy, similar studies in other countries have successfully established databases that have improved understanding and treatment of the disease.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to give informed consent prior to any study specific procedure being performed; * Diagnosis of PSC according to the most recent published guidelines (EASL); Exclusion Criteria: * Subject unwilling to participate at the study
Where it's running
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ASST Monza
Monza, Italy Recruiting -
Ospedali riuniti di Ancona
Ancona, Italy Not yet recruiting -
Policlinico di Bari
Bari, Italy Not yet recruiting -
ASST Bergamo ovest
Bergamo, Italy Not yet recruiting -
ASST Papa Giovanni XXIII
Bergamo, Italy Not yet recruiting -
Ospedale Sant'Orsola Malpighi
Bologna, Italy Not yet recruiting
Show 44 more locations
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Policlinico S. Orsola Malpighi
Bologna, Italy Not yet recruiting -
Azienda sanitaria dell'Alto Adige
Bolzano, Italy Not yet recruiting -
Spedali civili
Brescia, Italy Not yet recruiting -
Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
Brescia, Italy Not yet recruiting -
Policlinico universitario Monserrato
Cagliari, Italy Not yet recruiting -
Presidio Ospedaliero San Michele ARNAS G. Brotzu
Cagliari, Italy Not yet recruiting -
Osp. "S de Bellis" - IRCCS
Castellana Grotte, Italy Not yet recruiting -
UO epatologia Ospedale Garibaldi
Catania, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria- Mater Domini
Catanzaro, Italy Not yet recruiting -
Ospedale Valduce
Como, Italy Not yet recruiting -
Unità operativa complessa di medicina interna- Azienda ospedaliera di Cosenza
Cosenza, Italy Not yet recruiting -
ASST di Cremona
Cremona, Italy Not yet recruiting -
Ospedale santa croce
Cuneo, Italy Not yet recruiting -
Presidio Ospedaliero di Faenza (RA)
Faenza, Italy Not yet recruiting -
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy Not yet recruiting -
Azienda ospedaliera universitaria careggi Firenze
Florence, Italy Not yet recruiting -
Azienda ospedaliera universitaria Careggi
Florence, Italy Not yet recruiting -
Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche
Foggia, Italy Not yet recruiting -
Ospedale Casa Sollievo della Sofferenza
Foggia, Italy Not yet recruiting -
ASST Valle Olona
Gallarate, Italy Not yet recruiting -
Policlinico San Martino
Genova, Italy Not yet recruiting -
Presìdio Ospedaliero "Giovanni Paolo II"
Lamezia Terme, Italy Not yet recruiting -
ASST Lecco
Lecco, Italy Not yet recruiting -
UO di epatologia clinica e biomolecolare. Università degli studi di Messina
Messina, Italy Not yet recruiting -
Az. Ospedaliera San Paolo- Polo universitario
Milan, Italy Not yet recruiting -
Istituto scientifico universitario San Raffaele
Milan, Italy Not yet recruiting -
Ospedale Niguarda Ca' Granda
Milan, Italy Not yet recruiting -
Ospedale San Giuseppe
Milan, Italy Not yet recruiting -
Policlinico di Milano
Milan, Italy Not yet recruiting -
Dipartimento Ospedaliero di Medicina Interna
Modena, Italy Not yet recruiting -
Fondazione Evangelica Villa Betania, Ospedale generale di Zona
Naples, Italy Not yet recruiting -
Ospedale policlinico Federico II di Napoli
Naples, Italy Not yet recruiting -
Università della Campania Luigi Vanvitelli
Naples, Italy Not yet recruiting -
Ospedale maggiore della carità
Novara, Italy Not yet recruiting -
Azienda Ospedaliera di Padova
Padova, Italy Not yet recruiting -
UO di Gastroenterologia Azienda ospedaliera di Padova
Padova, Italy Not yet recruiting -
Policlinico Paolo Giaccone
Palermo, Italy Not yet recruiting -
Azienda ospedaliero universitaria di Parma
Parma, Italy Not yet recruiting -
Istituto Clinico Città di Pavia-Gruppo Sandonato
Pavia, Italy Not yet recruiting -
Azienda ospedaliera di Perugia
Perugia, Italy Not yet recruiting -
Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara
Pescara, Italy Not yet recruiting -
Aou pisana Cisanello
Pisa, Italy Not yet recruiting -
Ospedale di Pordenone AS FO
Pordenone, Italy Not yet recruiting
+13 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Pietro Invernizzi, MD
- Email: pietro.invernizzi@unimib.it
- Phone: 039 233 2187
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Elafibranor for adults with primary sclerosing cholangitis
This trial will see if taking elafibranor once daily helps adults with primary sclerosing cholangitis compared with a placebo.
-
TAK-781 treatment in healthy adults and people with non-cirrhotic primary sclerosing cholangitis
This study will test whether TAK-781 is safe and tolerable in healthy adults and in people with non-cirrhotic primary sclerosing cholangitis while measuring how the body handles and responds to the drug.
-
Preventing recurrence of primary sclerosing cholangitis after liver transplantation
This study is testing if a daily medication called fenofibrate can help prevent primary sclerosing cholangitis from coming back in people who have had a liver transplant.
-
LEOPARD: Predicting liver transplant dropout with AI in European patients
This project tests new AI-based models to predict which liver transplant candidates are at highest risk of dropout or death while on the waitlist.
-
Collecting data to improve liver transplantation predictions
This study is trying to use AI to better predict which liver transplant candidates are at risk of dropping out of the waitlist, so that more people can get fair access to transplants across Europe.
-
Identifying liver disease-specific gut microbiomes
This study is trying to find out if certain gut bacteria are linked to chronic liver diseases in adults, including autoimmune hepatitis and primary biliary cholangitis, by analyzing blood and stool samples from patients and their household members.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.