NCT03041662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

February 1, 2017

Last Update Submit

September 8, 2021

Conditions

Primary Sclerosing CholangitisCholangiocarcinoma

Outcome Measures

Primary Outcomes (3)

  • cholangiocarcinoma

    cholangiocarcinoma

    10 yrs f-up

  • liver transplatation

    liver transplatation

    10 yrs f-up

  • death

    death

    10 yrs f-up

Secondary Outcomes (1)

  • biliary dysplasia

    10 yrs f-up

Interventions

MR/MRCPDIAGNOSTIC_TEST

MR/MRCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

National Swedish cohort of PSC patients followed at 14 hospitals

You may qualify if:

  • Diagnosis of PSC by MR/MRCP
  • Life expectancy \>1 year
  • Informed consent

You may not qualify if:

  • Liver transplantation or on the waiting list
  • Secondry SC
  • Diagnosis of CCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Huddinge

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Cholangitis, SclerosingCholangiocarcinoma

Condition Hierarchy (Ancestors)

CholangitisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 3, 2017

Study Start

October 31, 2011

Primary Completion

October 31, 2016

Study Completion

November 30, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

SE(1)