Surveillance Study for Early Detection of Cholangiocarcin... | NCT03041662

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

NCT03041662

Sponsor

Karolinska University Hospital

Status

Completed

Last Update Posted

Sep 16, 2021Actual

Enrollment

620Actual

Phase

Not provided

Conditions

Primary Sclerosing Cholangitis
Cholangiocarcinoma

Interventions

MR/MRCP

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2011Actual

Primary Completion Date

Oct 31, 2016Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Feb 1, 2017

First Submission Date that Met QC Criteria

Feb 2, 2017

First Posted Date

Feb 3, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2021

Last Update Posted Date

Sep 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

620Actual

Name	Type	Description	Arm Group Labels	Other Names
MR/MRCP	Diagnostic Test	MR/MRCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cholangiocarcinoma	cholangiocarcinoma	10 yrs f-up
liver transplatation	liver transplatation	10 yrs f-up
death	death	10 yrs f-up

Secondary Outcomes

Measure	Description	Time Frame
biliary dysplasia	biliary dysplasia	10 yrs f-up

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

National Swedish cohort of PSC patients followed at 14 hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital, Huddinge		Stockholm		14186	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015209	Cholangitis, Sclerosing
D018281	Cholangiocarcinoma

Ancestor Terms

ID	Term
D002761	Cholangitis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided