Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)

Completed

• Conditions: Primary Sclerosing Cholangitis; Cholangiocarcinoma

• Registration Number: NCT03041662
• Lead Sponsor: Karolinska University Hospital

Brief Summary

This observational study of a national cohort of 600 Swedish PSC patients include yearly MR/MRCP, biobanking of serum, plasma and blood, followup clinical data (interventions, symptoms, labs, colonoscopy). The aim is to collect a well characterized cohort of PSC patients and provide future possibilities to evaluate biomarkers for prognosis and early cancer detection.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-31
• Primary Completion: 2016-10-31
• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Completion: 2020-11-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

• Diagnosis of PSC by MR/MRCP
• Life expectancy >1 year
• Informed consent

Exclusion Criteria

• Liver transplantation or on the waiting list
• Secondry SC
• Diagnosis of CCA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
liver transplatation	10 yrs f-up	liver transplatation
death	10 yrs f-up	death
cholangiocarcinoma	10 yrs f-up	cholangiocarcinoma

Secondary Outcome Measures

Name	Time	Method
biliary dysplasia	10 yrs f-up	biliary dysplasia

Trial Locations

Locations (1)

Karolinska University Hospital, Huddinge; 🇸🇪 Stockholm, Sweden