UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	HLA typing of cases with ulcerative colitis and Crohn's disease
Title of the study (Brief title)	HLA typing of cases with ulcerative colitis and Crohn's disease
Region	Japan

Condition
Condition	ulcerative colitis Crohn's disease
Classification by specialty	Gastroenterology Pediatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	We examine HLA typing of cases including familial occurence with ulcerative colitis and Crohn's disease to compare with HLA typing reported previously and identify novel HLA typing associating with pathogenesis of these diseases.
Basic objectives2	Others
Basic objectives -Others	We provide common HLA typing of ulcerative colitis and Crohn's disease.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examination of HLA typing of cases with ulcerative colitis and Crohn's disease
Key secondary outcomes

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	Gene
Interventions/Control_1	Blood sample is collected and HLA allele typing is performed.
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	Ulcerative colitis patient We recruit ulcerative colitis patients. Their age, gender and medicines are not concern. Crohn's disease We recruit Crohn's disease patients. Their age, gender and medicines are not concern.
Key exclusion criteria	1. Patients who dose not agree with participation in this study. 2. Patients judged inappropriate to incorporate this study.
Target sample size	5

Research contact person
Name of lead principal investigator	Yasuhiko SERA
Organization	National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name	Department of Pediatrics
Address	3-1 Aoyama-cho, Kure, Hiroshima
TEL	0823-22-3111
Email	seray@kure-nh.go.jp

Public contact
Name of contact person	Yasuhiko SERA
Organization	National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name	Department of Pediatrics
Address	3-1 Aoyama-cho, Kure, Hiroshima
TEL	0823-22-3111
Homepage URL
Email	seray@kure-nh.go.jp

Sponsor
Institute	National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 29 Day
Anticipated trial start date	2017 Year 07 Month 31 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

Management information
Registered date	2017 Year 07 Month 21 Day
Last modified on	2017 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031823