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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041662
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Annika Bergquist, Karolinska University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Primary Sclerosing Cholangitis Cholangiocarcinoma Diagnostic Test: MR/MRCP

Study Design
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Study Type : Observational
Actual Enrollment : 620 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Actual Study Start Date : October 31, 2011
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

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Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: MR/MRCP
    MR/MRCP

Outcome Measures
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Primary Outcome Measures :
  1. cholangiocarcinoma [ Time Frame: 10 yrs f-up ]
  2. liver transplatation [ Time Frame: 10 yrs f-up ]
  3. death [ Time Frame: 10 yrs f-up ]

Secondary Outcome Measures :
  1. biliary dysplasia [ Time Frame: 10 yrs f-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
National Swedish cohort of PSC patients followed at 14 hospitals
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041662


Locations
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Sweden
Karolinska University Hospital, Huddinge
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
More Information
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Responsible Party: Annika Bergquist, professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03041662    
Other Study ID Numbers: 2011/2:6
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Cholangitis
Cholangitis, Sclerosing
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases