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NCT03041662 Clinical Trial

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

Cholangiocarcinoma Clinical Trial

— PSC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03041662
Other study ID # 2011/2:6
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 31, 2011
Est. completion date November 30, 2020

Study information
Verified date September 2021
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 620
Est. completion date November 30, 2020
Est. primary completion date October 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MR/MRCP
MR/MRCP

Locations
Country Name City State
Sweden Karolinska University Hospital, Huddinge Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary cholangiocarcinoma cholangiocarcinoma 10 yrs f-up
Primary liver transplatation liver transplatation 10 yrs f-up
Primary death death 10 yrs f-up
Secondary biliary dysplasia biliary dysplasia 10 yrs f-up
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