UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003519 |
|---|---|
| Receipt number | R000003782 |
| Scientific Title | Genetic study of autoimmune pancreatitis and IgG4-related diseases. |
| Date of disclosure of the study information | 2010/04/22 |
| Last modified on | 2016/04/23 19:40:54 |
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Basic information
Public title
Genetic study of autoimmune pancreatitis and IgG4-related diseases.
Acronym
Genetic study of AIP
Scientific Title
Genetic study of autoimmune pancreatitis and IgG4-related diseases.
Scientific Title:Acronym
Genetic study of AIP
Region
| Japan |
Condition
Condition
IgG4 related disease, autoimmune pnacreatitis, and the cases with differential diagnosis to IgG4-related diseases (chronic pancreatitis (alcohol, idiopathic etc), Sjogren's syndrome, primary sclerosing cholangitis, interstitial nephritis, interstitial pneuminia, retoroperitoneal fibrosis, pseudo tumor, etc)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identyfy specific genes associated with autoimmune pancreatitis and IgG4-related diseases.
Basic objectives2
Others
Basic objectives -Others
To apply the genomic information to diagnosis and treatment of AIP and IgG4-related diseases.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
GWAS, epigenetics
Key secondary outcomes
Clinical data of AIP and IgG4-related diseases.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
blood sampling
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with AIP diagnosed according to Asian criteria for AIP or suspicious of AIP.
Patients with IgG4-related diseases or suspicious of IgG4-related disease.
Patients with alcoholic pancreatitis.
Patients with idiopathic pancreatitis.
Patients with biliary stone-related pancreatitis.
Patients with Sjogren's syndrome.
Patients with interstitial nephritis.
Patients with interstitial pneuminia.
Patients with primary sclerosing cholangitis.
Patients who needs differential diagnosis to IgG4 related diseases.
Key exclusion criteria
Patients without the agreement to join this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiba tsutomu |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Shogoinkawatamatch, Sakyo-ku, Kyoto,Japan
TEL
075-751-4319
kodamayu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kodama Yuzo |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
54 Shogoinkawatamatch, Sakyo-ku, Kyoto,Japan
TEL
075-751-4319
Homepage URL
kodamayu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology,Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Intractable Diseases, the Health and Labor Sciences Research Grants from Minister of Labor and Welfare of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Center for Genomic Medicine, Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
関西医科大学 (大阪府)
信州大学病院（長野県）
都立駒込病院（東京都）
鹿児島大学病院（鹿児島県）
慶應義塾大学病院（東京都）
京都大学病院（京都府）
金沢医科大学（石川県）
東北大学病院（宮城県）
九州大学病院（福岡県）
国立病院機構京都医療センター（京都府）
倉敷中央病院（岡山県）
名古屋大学病院（愛知県）
名古屋市立大学病院（愛知県）
東京大学病院（東京都）
昭和大学病院
藤田保険衛生大学坂文種報德會病院（愛知県）
愛知がんセンター中央病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 22 | 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
| 2010 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 22 | Day |
Last modified on
| 2016 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003782
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