Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC) (PSC)
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ClinicalTrials.gov Identifier: NCT03041662 |
Recruitment Status :
Completed
First Posted : February 3, 2017
Last Update Posted : February 3, 2017
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Sponsor:
Karolinska University Hospital
Information provided by (Responsible Party):
Annika Bergquist, Karolinska University Hospital
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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 |
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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 |
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Intervention | Diagnostic Test: MR/MRCP
MR/MRCP
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |