UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	genomic and epigenomic analysis in inflammatory bowel disease for investigation of pathogenes and mechanism of resistance to anti-TNF therapy.
Title of the study (Brief title)	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	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,
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo,
TEL	03-3353-1211
Email	hisamachi@a7.keio.jp

Public contact
Name of contact person	Tadakazu Hisamatsu
Organization	School of Medicine, Keio University
Division name	Div. of Gastroenterology and hepatology, Dep. of Internal Medicine,
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	the recruitment of this study was finished.
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