National Database on Primary Sclerosing Cholangitis (PSC)
ConditionPrimary Sclerosing Cholangitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age17+
SponsorUniversity of Milano Bicocca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
Subject unwilling to participate at the study
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical information
Other interventionThe investigators will recruit PSC patients and collect important clinical information and laboratory investigation, together with biological samples.
Treatment groups
6,000 Participants
are divided into 1 treatment groupGroup A: PSC population residing in Italy1 intervention
Trial outcomes
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.
Time frame
Overall duration of the study (10 years)Secondary outcomes
1
Identification of factors associated with response to therapies;
Identification of factors associated with response to therapies;
Time frame
Overall duration of the study (10 years)2
Identification of biomarkers influencing the progression of PSC and affecting mortality
Identification of biomarkers influencing the progression of PSC and affecting mortality
Time frame
Overall duration of the study (10 years)3
Assessment of safety and long-term efficacy of novel therapies
Assessment of safety and long-term efficacy of novel therapies
Time frame
Overall duration of the study (10 years)Sponsors and contacts
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Source ClinicalTrials.gov