IgG4-related Sclerosing CholangitisNCT02616705
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
An observational study of IgG4-related Sclerosing Cholangitis and IgG4-related Disease, run by Mayo Clinic at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgG4-related Sclerosing Cholangitis, IgG4-related Disease
- How many people
- 511 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cases with biliary stricture(s) of any cause
Who may be able to join
- The presence of a biliary stricture
- 18 years and older
- Consented to IRB 707-03
Who cannot join
- Younger than 18 years of age
- Unable to collect a bile sample
- Abnormal postsurgical anatomy preventing collection of a bile sample
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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.
Read the 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.
- Medical subject headings
- Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 year
Secondary outcomes (1)
Correlation between bile and serum IgG4 concentrations.
The relationship between Bile and serum IgG4 concentrations will be assessed for case and controls, using appropriate statistical methods
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-related Sclerosing CholangitisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Nagoya University
- Responsible party
- Principal investigator, Lewis R. Roberts, Mayo Clinic
- Investigators
- Lewis R Roberts, MB, ChB, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616705
- Sponsor's protocol ID
- 15-004819
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2015
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data sharing could be arranged and will require IRB approval
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis
- ClinicalTrials.gov ID
- NCT02616705
- Acronym / sponsor ID
- 15-004819
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Nagoya University
- Study start
- Nov 2015
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cases with biliary stricture(s) of any cause
Key inclusion criteria (3 listed)
- The presence of a biliary stricture
- 18 years and older
- Consented to IRB 707-03
Key exclusion criteria (3 listed)
- Younger than 18 years of age
- Unable to collect a bile sample
- Abnormal postsurgical anatomy preventing collection of a bile sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Correlation between bile and serum IgG4 concentrations.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data sharing could be arranged and will require IRB approval
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis R Roberts, MB, ChB, PhD principal investigator
Mayo Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IgG4-related Sclerosing Cholangitis and IgG4-related Disease, run by Mayo Clinic at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of bile IgG4 concentration to distinguish between IgG4-SC, PSC, and CCA. (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.