UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006681 |
|---|---|
| Receipt number | 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 14:10:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hisamachi@a7.keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007893
