UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028323 |
|---|---|
| Receipt number | 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 15:38:50 |
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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
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
seray@kure-nh.go.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031823
