UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002341 |
|---|---|
| Receipt number | R000002868 |
| Scientific Title | Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease |
| Date of disclosure of the study information | 2009/08/18 |
| Last modified on | 2014/02/17 12:24:44 |
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Basic information
Public title
Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease
Acronym
Biomarkers of Crohn's disease
Scientific Title
Investigation of biomarkers for predicting effectiveness of treatments for Crohn's disease
Scientific Title:Acronym
Biomarkers of Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate biomarkers for predicting effectiveness of Infliximab for the treatment of the patients with Crohn's disease
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of 50 cytokines by multiplex array system and clinica activity of Crohn's disease
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Crohn's disease elder than 16 years old who need treatments with Infliximab and gave written informed consent.
Key exclusion criteria
Patients with Crohn's disease who are not applicable to Infliximab treatment and who do not give written informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2- Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
81-6-6879-3621
hiijima@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
+81-6-6879-3621
Homepage URL
http://www.med.osaka-u.ac.jp/pub/gh/index.htm
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Intractable Diseases Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 08 | Month | 18 | 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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serum samples from patients with Crohn's disease are collected before, 2 wks, 6 wks, 6Mos, 12Mos after the treatemt with Infliximab and are analyzed for the expressions of cytokines, chemokine and adhesion molecules by Bio-Plex assay.
Management information
Registered date
| 2009 | Year | 08 | Month | 17 | Day |
Last modified on
| 2014 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002868
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
