UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052983 |
|---|---|
| Receipt number | R000060444 |
| Scientific Title | Clinical characteristics of IgG4-related cholecystitis |
| Date of disclosure of the study information | 2023/12/03 |
| Last modified on | 2023/12/03 15:35:11 |
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Basic information
Public title
Clinical characteristics of IgG4-related cholecystitis
Acronym
Clinical characteristics of IgG4-related cholecystitis
Scientific Title
Clinical characteristics of IgG4-related cholecystitis
Scientific Title:Acronym
Clinical characteristics of IgG4-related cholecystitis
Region
| Japan |
Condition
Condition
IgG4-related cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical characteristics of IgG4-related cholecystitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical, imaging and histopathological characteristics of IgG4-related cholecystitis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. IgG4-related cholecystitis confirmed histopathologically
2. IgG4-related cholecystitis immproved by steroid therapy
Key exclusion criteria
Patients who reject to participate this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Naitoh |
Organization
Nagoya City University Midori Municipal Hospital
Division name
Department of Gastroenterology
Zip code
458-0037
Address
1-77 Shiomigaoka, Midori-Ku, Nagoya
TEL
052-892-1331
inaito@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Naitoh |
Organization
Nagoya City University Midori Municipal Hospital
Division name
Department of Gastroenterology
Zip code
458-0037
Address
1-77 Shiomigaoka, Midori-Ku, Nagoya
TEL
052-892-1331
Homepage URL
inaito@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Midori Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Midori Municipal Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Centre, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
irb_jimu@med.nagoya-cu.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
北海道大学、関西医科大学、東北大学、静岡がんセンター、倉敷中央病院、金沢大学、駒込病院、名古屋市立大学、神戸大学、名古屋大学、自治医科大学、京都大学、岐阜県立多治見病院、帯広厚生病院、伊勢崎市民病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 03 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the clinical, imaging and histopathological characteristics of IgG4-related cholecystitis
Management information
Registered date
| 2023 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060444
