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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 31, 2016

Interventions

  • Diagnostic Test: MR/MRCP
    • MR/MRCP

Clinical Trial Outcome Measures

Primary Measures

  • cholangiocarcinoma
    • Time Frame: 10 yrs f-up
  • liver transplatation
    • Time Frame: 10 yrs f-up
  • death
    • Time Frame: 10 yrs f-up

Secondary Measures

  • biliary dysplasia
    • Time Frame: 10 yrs f-up

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Karolinska University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Annika Bergquist, professor – Karolinska University Hospital

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