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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005435
Receipt No. R000006450
Scientific Title genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and resistance to anti-TNF therapy the mechanisms of
Date of disclosure of the study information 2011/04/14
Last modified on 2018/03/27

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Basic information
Public title genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and resistance to anti-TNF therapy the mechanisms of
Acronym genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and the mechanisms of resistance to anti-TNF therapy
Scientific Title genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and resistance to anti-TNF therapy the mechanisms of
Scientific Title:Acronym genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and the mechanisms of resistance to anti-TNF therapy
Region
Japan

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

Objectives
Narrative objectives1 epigenomic analysis for investigation of pathogenesis and the mechanisms of resistance to anti-TNFa antibody
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes epigenomic alteration
response to anti-TNFa antibody
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 the patients with Crohn's disease who will be received anti-TNFa antibody therapy
Key exclusion criteria the patients that we cannot obtain the agreement (by IC form) about this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TADAKAZU HISAMATSU
Organization Div. of Gastroenterology and hepatology, Dep. of Internal Medicine, School of Medicine, Keio University
Division name Div. of Gastroenterology and hepatology, Dep. of Internal Medicine,
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email hisamachi@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name TADAKAZU HISAMATSU
Organization School of Medicine, Keio University
Division name Div. of Gastroenterology and hepatology, Dep. of Internal Medicine,
Zip code
Address Shinanomachi35, Shinjyuku-ku
TEL 03-3353-1211
Homepage URL
Email hisamachi@a7.keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2011 Year 04 Month 14 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
the recruitment of this study was finished.
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 Completed
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information the adult Crohn's disease patients who will be received anti-TNFa therapy

Management information
Registered date
2011 Year 04 Month 13 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006450

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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