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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03041662

Acronym

PSC

Enrollment

620

Registered

2017-02-03

Start date

2011-10-31

Completion date

2020-11-30

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma, Primary Sclerosing Cholangitis

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.

Interventions

DIAGNOSTIC_TESTMR/MRCP

MR/MRCP

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
cholangiocarcinoma	10 yrs f-up	cholangiocarcinoma
liver transplatation	10 yrs f-up	liver transplatation
death	10 yrs f-up	death

Secondary

Measure	Time frame	Description
biliary dysplasia	10 yrs f-up	biliary dysplasia

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026