UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Genome wide analysis and combined omix analysis of patients with eosinophilic esophagitis and eosinophilic gastroenteritis
Title of the study (Brief title)	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	Yoshikazu Kinoshita
Organization	Shimane University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	89-1 Enya-cho, Izumo, Shimane 693-8501
TEL	0853-20-2190
Email	kinosita@med.shimane-u.ac.jp

Public contact
Name of contact person	Norihisa Ishimura
Organization	Shimane University Faculty of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	89-1 Enya-cho, Izumo, Shimane 693-8501
TEL	0853-20-2190
Homepage URL
Email	ishimura@med.shiman-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Shimane University Faculty of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 02 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015993