Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
1 other identifier
observational
511
2 countries
2
Brief Summary
Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
2 active sites
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
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 23, 2015
CompletedFirst Posted
Study publicly available on registry
November 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJanuary 5, 2022
January 1, 2022
3.9 years
November 23, 2015
January 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA.
Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods
2 year
Secondary Outcomes (1)
Correlation between bile and serum IgG4 concentrations.
2 years
Study Arms (2)
IgG4-related sclerosing cholangitis
Patients with IgG4-related sclerosing cholangitis (also called IgG4 associated cholangitis, IgG4 related cholangitis, or biliary IgG4-related disease)
Controls
cholangiocarcinoma, PSC, and other patients with biliary strictures
Eligibility Criteria
Cases with biliary stricture(s) of any cause
You may qualify if:
- The presence of a biliary stricture
- years and older
- Consented to IRB 707-03
You may not qualify if:
- Younger than 18 years of age
- Unable to collect a bile sample
- Abnormal postsurgical anatomy preventing collection of a bile sample
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Nagoya Universitycollaborator
Study Sites (2)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Nagoya City Universty Graduate School of Medical Sciences
Nagoya, Japan
Related Links
Biospecimen
Bile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lewis R Roberts, MB, ChB, PhD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 23, 2015
First Posted
November 30, 2015
Study Start
November 1, 2015
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
January 5, 2022
Record last verified: 2022-01