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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006681
Receipt No. R000007893
Scientific Title genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and mechanism of resistance to anti-TNF therapy.
Date of disclosure of the study information 2011/11/07
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 mechanism of resistance to anti-TNF therapy.
Acronym genomic analysis in inflammatory bowel disease for investigation of the mechanisms of resistance to anti-TNF therapy
Scientific Title genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and mechanism of resistance to anti-TNF therapy.
Scientific Title:Acronym genomic analysis in inflammatory bowel disease for investigation of the mechanisms of resistance to anti-TNF therapy
Region
Japan

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

Objectives
Narrative objectives1 To identify the mechanism of resistance to anti-TNFa therapy using genomic analysis.
Basic objectives2 Others
Basic objectives -Others To identify the mechanism of resistance to anti-TNFa therapy using genomic analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes genomic factor for resistance in 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 and ulcerative colitis who are 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 60

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,
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, Tokyo
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
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 11 Month 07 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information the adult Crohn's disease and ulcerative colitis patients who are received anti-TNFa therapy

Management information
Registered date
2011 Year 11 Month 07 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=R000007893

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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