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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

Tracking Information
First Submitted Date February 1, 2017
First Posted Date February 3, 2017
Last Update Posted Date February 3, 2017
Actual Study Start Date October 31, 2011
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 2, 2017)
  • cholangiocarcinoma [ Time Frame: 10 yrs f-up ]
  • liver transplatation [ Time Frame: 10 yrs f-up ]
  • death [ Time Frame: 10 yrs f-up ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 2, 2017)
biliary dysplasia [ Time Frame: 10 yrs f-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Official Title Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population National Swedish cohort of PSC patients followed at 14 hospitals
Condition
  • Primary Sclerosing Cholangitis
  • Cholangiocarcinoma
Intervention Diagnostic Test: MR/MRCP
MR/MRCP
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 2, 2017)
620
Original Actual Enrollment Same as current
Actual Study Completion Date October 31, 2016
Actual Primary Completion Date October 31, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03041662
Other Study ID Numbers 2011/2:6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Annika Bergquist, Karolinska University Hospital
Study Sponsor Karolinska University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Karolinska University Hospital
Verification Date February 2017