National Database on Primary Sclerosing Cholangitis (PSC)
Observational · No treatment assigned · 63 sites · University of Milano Bicocca
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Primary Sclerosing Cholangitis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 17 and older
- Any sex
Some of the main requirements, copied from the record:
- 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);
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 6000 participants are expected to take part.
- The study has 1 group.
- Start date: 2022-10-21.
- Main results expected around 2032-10-21 (estimate from the record).
- 63 study sites listed (1 marked recruiting) in Italy.
Groups in this study
- PSC population residing in Italy
Main thing being measured
- Identify and define distinct phenotypes and sub-phenotypes of PSC patients at higher risk of disease progression. (Overall duration of the study (10 years))
In the researchers’ words
Primary sclerosing cholangitis (PSC) a rare, chronic fibroinflammatory disease of the liver. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PSC patient database linked to a biological sample storage.
Words you might see
- Biologic: a medicine made from living cells, usually given by injection or infusion.
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 | Observational |
| Study type | Observational |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | University of Milano Bicocca |
| Enrollment | 6000 (estimated) |
| Start date | 2022-10-21 |
| Primary completion (est.) | 2032-10-21 |
| First posted | 2022-11-16 |
| Last updated | 2024-01-02 |
| 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 |
| ClinicalTrials.gov ID | NCT05618145 |
Interventions
- Clinical information (Other)
The investigators will recruit PSC patients and collect important clinical information and laboratory investigation, together with biological samples.
Full eligibility criteria (from the record)
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
Locations (63)
Show all 63 sites
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
| 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 |
| ASST Monza | Monza | Italy | 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 |
| Ospedale San Carlo | Potenza | Italy | Not yet recruiting |
| Azienda unità sanitaria locale della Romagna | Rimini | Italy | Not yet recruiting |
| Ospedale A. Gemelli | Roma | Italy | Not yet recruiting |
| Policlinico Umberto I | Roma | Italy | Not yet recruiting |
| Policlinico universitario campus bio-medico | Roma | Italy | Not yet recruiting |
| Universita' di Roma Tor Vergata | Roma | Italy | Not yet recruiting |
| Istituto clinico Humanitas | Rozzano | Italy | Not yet recruiting |
| Università degli studi di Salerno | Salerno | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Molinette | Torino | Italy | Not yet recruiting |
| Azienda provinciale per i servizi sanitari | Trento | Italy | Not yet recruiting |
| Ospedale di Cattinara, ASU GI | Trieste | Italy | Not yet recruiting |
| ASU FC | Udine | Italy | Not yet recruiting |
| ASST Sette Laghi | Varese | Italy | Not yet 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.