UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057749 |
|---|---|
| Receipt number | R000065193 |
| Scientific Title | A prospective observational study aimed at elucidating the pathogenesis of IgG4-related disease |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/05/01 01:22:21 |
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Basic information
Public title
A prospective observational study aimed at elucidating the pathogenesis of IgG4-related disease
Acronym
A prospective observational study aimed at elucidating the pathogenesis of IgG4-related disease
Scientific Title
A prospective observational study aimed at elucidating the pathogenesis of IgG4-related disease
Scientific Title:Acronym
A prospective observational study aimed at elucidating the pathogenesis of IgG4-related disease
Region
| Japan |
Condition
Condition
IgG4-related disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate a novel pathophysiological mechanism linking intestinal immunity to the onset of IgG4-related disease.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between IgG4-related disease and gut microbiota analysis.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between IgG4-related disease and gut microbiota analysis.
Key secondary outcomes
Clinical, imaging, and pathological characteristics of IgG4-related gastrointestinal disease
Changes in gut microbiota and various cytokines before and after steroid treatment in IgG4-related disease
Relationship between the local microbiota of affected organs and gut microbiota in IgG4-related disease
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with IgG4-related disease.
Patients aged 18 years or older at the time of obtaining consent.
Patients who have received a thorough explanation about participation in this study and have provided written consent voluntarily, either by themselves or through a legal representative.
Key exclusion criteria
Patients who do not provide consent for this study.
Patients deemed unsuitable as research subjects by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yujiro |
| Middle name | |
| Last name | Kawakami |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8556
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
yujiro-k@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Kawakami |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8556
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
https://sapporo-med-gastroenterology.jp/patients/
yujiro-k@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Hospital Clinical Research Support Center
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A single center prospective study
Management information
Registered date
| 2025 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065193
