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

• ClinicalTrials.gov Identifier: NCT03041662
• Recruitment Status: Completed
• First Posted: February 3, 2017
• Last Update Posted: February 3, 2017
• Sponsor: Karolinska University Hospital
• 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

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

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