UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013699 |
|---|---|
| Receipt number | R000015993 |
| Scientific Title | Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis |
| Date of disclosure of the study information | 2014/04/12 |
| Last modified on | 2016/10/18 23:34:29 |
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Basic information
Public title
Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Acronym
Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Scientific Title
Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Scientific Title:Acronym
Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Region
| Japan |
Condition
Condition
eosinophilic gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the disease mechanisms through GWAS and OMICS analysis in patients with eosinophilic gastrointestinal disorders
Basic objectives2
Others
Basic objectives -Others
To identify risk variants for eosinophilic gastrointestinal disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
genetic variants and disease susceptibility
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with eosinophilic gastrointestinal disorders based on the guideline
2. Patients with written informed consent
Key exclusion criteria
Nothing particular
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501
TEL
0853-20-2190
Homepage URL
ishimura@med.shiman-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
島根大学医学部（島根県）, 京都大学医学部（京都府）, 京都大学医学研究科附属ゲノム医学センター（京都府）, 福岡大学筑紫病院（福岡県）, 九州大学病院（福岡県）, 東北労災病院（宮城県）, 東北大学医学部（宮城県），大阪市立大学医学部（大阪府），山形大学医学部（山形県），藤田保健衛生大学（愛知県），兵庫医科大学（兵庫県），群馬大学（群馬県），慶應大学（東京都），松江市立病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 12 | 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
| 2013 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 04 | Month | 12 | Day |
Last modified on
| 2016 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015993
