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Completed

NCT Number: NCT03041662

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

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.

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Key information

Conditions

Primary Sclerosing Cholangitis Adenocarcinoma Bile Duct Diseases Biliary Tract Diseases Carcinoma Cholangiocarcinoma Cholangitis Cholangitis, Sclerosing Digestive System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR/MRCP

Diagnostic Test

MR/MRCP

Primary outcomes

  1. cholangiocarcinoma

    Time frame: 10 yrs f-up

    cholangiocarcinoma

  2. liver transplatation

    Time frame: 10 yrs f-up

    liver transplatation

  3. death

    Time frame: 10 yrs f-up

    death

Secondary outcomes

  1. biliary dysplasia

    Time frame: 10 yrs f-up

    biliary dysplasia

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Acronym: PSC

Important dates

Study start
2011
Primary completion
2016
Study completion
2020
First posted
Feb 3, 2017
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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