UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028323
Receipt No. R000031823
Scientific Title HLA typing of cases with ulcerative colitis and Crohn's disease
Date of disclosure of the study information 2017/07/28
Last modified on 2017/07/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title HLA typing of cases with ulcerative colitis and Crohn's disease
Acronym HLA typing of cases with ulcerative colitis and Crohn's disease
Scientific Title HLA typing of cases with ulcerative colitis and Crohn's disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiko SERA
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Pediatrics
Zip code
Address 3-1 Aoyama-cho, Kure, Hiroshima
TEL 0823-22-3111
Email seray@kure-nh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiko SERA
Organization National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name Department of Pediatrics
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 29 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.