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Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT02616705
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Nagoya University
Information provided by (Responsible Party):
Mark Topazian, Mayo Clinic

Tracking Information
First Submitted Date November 23, 2015
First Posted Date November 30, 2015
Last Update Posted Date August 9, 2018
Study Start Date November 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2015)
Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA. [ Time Frame: 2 year ]
Bile concentration of IgG4 will be measured in cases and controls, and the groups will be compared using appropriate statistical methods
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02616705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 27, 2015)
Correlation between bile and serum IgG4 concentrations. [ Time Frame: 2 years ]
The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods
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 Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
Official Title Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
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.
Detailed Description This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Bile
Sampling Method Non-Probability Sample
Study Population Cases with biliary stricture(s) of any cause
Condition
  • IgG4-related Sclerosing Cholangitis
  • IgG4-related Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 27, 2015)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The presence of a biliary stricture
  • 18 years and older
  • Consented to IRB 707-03

Exclusion Criteria:

  • Younger than 18 years of age
  • Unable to collect a bile sample
  • Abnormal postsurgical anatomy preventing collection of a bile sample
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mark D. Topazian, M.D. 507-26-6931 Topazian.Mark@mayo.edu
Contact: Katsuyuki Miyabe, M.D., Ph.D. 507-538-4877 miyabe.katsuyuki@mayo.edu
Listed Location Countries Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02616705
Other Study ID Numbers 15-004819
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Data sharing could be arranged and will require IRB approval
Responsible Party Mark Topazian, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Nagoya University
Investigators
Principal Investigator: Mark D. Topazian, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2018