UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052984 |
|---|---|
| Receipt number | R000060445 |
| Scientific Title | Validation study of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020 |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/03 16:24:09 |
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Basic information
Public title
Validation study of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Acronym
Validation study of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Scientific Title
Validation study of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Scientific Title:Acronym
Validation study of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Region
| Japan |
Condition
Condition
IgG4-related sclerosing cholangitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic ability of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic ability of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
Key secondary outcomes
1.Comparison of doagnostic ability between clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020 and 2012
2.Evaluationof the cases not daignosed as IgG4-related sclerosing cholangitis based on clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
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. The cases of definite, probable or possible diagnoses on the basis of clinical diagnostic criteria for IgG4-SC 2020.
2. The cases of definite, probable or possible diagnoses on the basis of clinical diagnostic criteria for IgG4-SC 2012.
Key exclusion criteria
Patients who reject to participate this study
Target sample size
1000
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
東北大学大学院、関西医科大学附属病院、鹿児島大学大学院医歯学総合研究科、東京医科大学、金沢大学附属病院、獨協医科大学病院、慶應義塾大学医学部、福岡大学筑紫病院、高知大学医学部、信州大学医学部附属病院、岡山大学病院、がん・感染症センター都立駒込病院、名古屋大学医学部附属病院、横浜市立大学附属病院、北海道大学病院、神戸大学大学院医学研究科、京都大学大学院医学研究科、福島県立医科大学、帝京大学医学部、札幌医科大学、東京女子医科大学附属八千代医療センター、倉敷中央病院、新潟大学大学院医歯学総合研究科、東京高輪病院、藤田医科大学、九州大学病院、名古屋市立大学大学院 医学研究科、静岡県立静岡がんセンター、富山大学附属病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 25 | 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 | 11 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | 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 validate the diagnostic ability of clinical diagnostic criteria for IgG4-related sclerosing cholangitis 2020
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/icdr_e/ctr_view.cgi?recptno=R000060445
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
