National Database on Primary Sclerosing Cholangitis (PSC)
Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patient's Database Linked to a Biological Sample Storage
1 other identifier
observational
6,000
1 country
63
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 21, 2022
CompletedFirst Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 21, 2032
January 2, 2024
December 1, 2023
10 years
November 8, 2022
December 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Identify and define distinct phenotypes and sub-phenotypes of PSC patients at higher risk of disease progression.
Identify and define distinct phenotypes and sub-phenotypes of PSC patients at higher risk of disease progression.
Overall duration of the study (10 years)
Secondary Outcomes (3)
Identification of factors associated with response to therapies;
Overall duration of the study (10 years)
Identification of biomarkers influencing the progression of PSC and affecting mortality
Overall duration of the study (10 years)
Assessment of safety and long-term efficacy of novel therapies
Overall duration of the study (10 years)
Study Arms (1)
PSC population residing in Italy
All PSC patients living in Italy and aged at least 17 years can be included in the database.
Interventions
The investigators will recruit PSC patients and collect important clinical information and laboratory investigation, together with biological samples.
Eligibility Criteria
All PSC patients living in Italy and aged at least 17 years can be included in the database. 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).
You may qualify if:
- 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);
You may not qualify if:
- Subject unwilling to participate at the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Ospedali riuniti di Ancona
Ancona, Italy
Policlinico di Bari
Bari, Italy
ASST Bergamo ovest
Bergamo, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale Sant'Orsola Malpighi
Bologna, Italy
Policlinico S. Orsola Malpighi
Bologna, Italy
Azienda sanitaria dell'Alto Adige
Bolzano, Italy
Spedali civili
Brescia, Italy
Unità epatologica ed ecografia internistica a valenza dipartimentale, Fondazione Ospedaliera Poliambulanza
Brescia, Italy
Policlinico universitario Monserrato
Cagliari, Italy
Presidio Ospedaliero San Michele ARNAS G. Brotzu
Cagliari, Italy
Osp. "S de Bellis" - IRCCS
Castellana Grotte, Italy
UO epatologia Ospedale Garibaldi
Catania, Italy
Azienda Ospedaliera Universitaria Mater Domini
Catanzaro, Italy
Azienda Ospedaliera Universitaria- Mater Domini
Catanzaro, Italy
Ospedale Valduce
Como, Italy
Unità operativa complessa di medicina interna- Azienda ospedaliera di Cosenza
Cosenza, Italy
ASST di Cremona
Cremona, Italy
Ospedale santa croce
Cuneo, Italy
Presidio Ospedaliero di Faenza (RA)
Faenza, Italy
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Italy
Azienda ospedaliera universitaria careggi Firenze
Florence, Italy
Azienda ospedaliera universitaria Careggi
Florence, Italy
Centro C.U.R.E. Centro Universitario per la ricerca e la Cura delle Malattie Epatiche
Foggia, Italy
Ospedale Casa Sollievo della Sofferenza
Foggia, Italy
ASST Valle Olona
Gallarate, Italy
Policlinico San Martino
Genova, Italy
Presìdio Ospedaliero "Giovanni Paolo II"
Lamezia Terme, Italy
ASST Lecco
Lecco, Italy
UO di epatologia clinica e biomolecolare. Università degli studi di Messina
Messina, Italy
Az. Ospedaliera San Paolo- Polo universitario
Milan, Italy
Istituto scientifico universitario San Raffaele
Milan, Italy
Ospedale Niguarda Ca' Granda
Milan, Italy
Ospedale San Giuseppe
Milan, Italy
Policlinico di Milano
Milan, Italy
Dipartimento Ospedaliero di Medicina Interna
Modena, Italy
ASST Monza
Monza, 20900, Italy
Fondazione Evangelica Villa Betania, Ospedale generale di Zona
Napoli, Italy
Ospedale policlinico Federico II di Napoli
Napoli, Italy
Università della Campania Luigi Vanvitelli
Napoli, Italy
Ospedale maggiore della carità
Novara, Italy
Azienda Ospedaliera di Padova
Padua, Italy
UO di Gastroenterologia Azienda ospedaliera di Padova
Padua, Italy
Policlinico Paolo Giaccone
Palermo, Italy
Azienda ospedaliero universitaria di Parma
Parma, Italy
Istituto Clinico Città di Pavia-Gruppo Sandonato
Pavia, Italy
Azienda ospedaliera di Perugia
Perugia, Italy
Day Hospital Internistico e ambulatorio di Epatologia, ASL Pescara
Pescara, Italy
Aou pisana Cisanello
Pisa, Italy
Ospedale di Pordenone AS FO
Pordenone, Italy
Ospedale San Carlo
Potenza, Italy
Azienda unità sanitaria locale della Romagna
Rimini, Italy
Ospedale A. Gemelli
Roma, Italy
Policlinico Umberto I
Roma, Italy
Policlinico universitario campus bio-medico
Roma, Italy
Universita' di Roma Tor Vergata
Roma, Italy
Istituto clinico Humanitas
Rozzano, Italy
Università degli studi di Salerno
Salerno, Italy
Azienda Ospedaliero-Universitaria Molinette
Torino, Italy
Azienda provinciale per i servizi sanitari
Trento, Italy
Ospedale di Cattinara, ASU GI
Trieste, Italy
ASU FC
Udine, Italy
ASST Sette Laghi
Varese, Italy
Biospecimen
Biological samples are collected at time of recruitment (blood, urine and liver tissue).The collection of liver tissue depends on the specific procedures that are performed based on clinical needs.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 16, 2022
Study Start
October 21, 2022
Primary Completion (Estimated)
October 21, 2032
Study Completion (Estimated)
October 21, 2032
Last Updated
January 2, 2024
Record last verified: 2023-12