UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043214 |
|---|---|
| Receipt number | R000049322 |
| Scientific Title | Observational study on pancreatic endocrine dysfunction in IgG4 related disease |
| Date of disclosure of the study information | 2021/02/02 |
| Last modified on | 2023/08/08 07:14:46 |
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Basic information
Public title
Observational study on pancreatic endocrine dysfunction in IgG4 related disease
Acronym
Pancreatic endocrine dysfunction in IgG4 related disease
Scientific Title
Observational study on pancreatic endocrine dysfunction in IgG4 related disease
Scientific Title:Acronym
Pancreatic endocrine dysfunction in IgG4 related disease
Region
| Japan |
Condition
Condition
IgG4 related disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between pancreatic dysfunction and histopathological features in the pancreas.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pancreatic endocrine function
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with IgG4 related disease
Key exclusion criteria
Patients without IgG4 related disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takeshima |
Organization
Wakayama medical University
Division name
First Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimi-idera, Wakayama
TEL
0734410625
kt10948@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takeshima |
Organization
Wakayama Medical University
Division name
First Department of Internal Medicine
Zip code
641-8509
Address
811-1 Kimi-idera, Wakayama
TEL
0734410625
Homepage URL
kt10948@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
Wakayama Medical University Hospital Ethics Committee
Address
811-1 Kimi-idera, Wakayama
Tel
0734410625
kt10948@wakayama-med.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
| 2021 | Year | 02 | Month | 02 | Day |
Related information
URL releasing protocol
Nothing
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The relationship between pancreatic dysfunction and pancreatic pathology
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049322
