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

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 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


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

Value
https://center6.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