UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010197 |
|---|---|
| Receipt number | R000011677 |
| Scientific Title | Identification of genetic biomarkers to determine blood concentration of therapeutic agents for inflammatory bowel disease. |
| Date of disclosure of the study information | 2013/03/10 |
| Last modified on | 2015/03/10 10:49:20 |
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Basic information
Public title
Identification of genetic biomarkers to determine blood concentration of therapeutic agents for inflammatory bowel disease.
Acronym
Genetic biomarkers to determine blood concentration of medication agents.
Scientific Title
Identification of genetic biomarkers to determine blood concentration of therapeutic agents for inflammatory bowel disease.
Scientific Title:Acronym
Genetic biomarkers to determine blood concentration of medication agents.
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We investigate the SNPs of IBD patients and analyze the relationship between 6-TGN blood concentration and SNPs. Finally, we determine the optimal dose of azathioprine based on the information of SNPs.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between blood 6-TGN concentration and dose of azathioprine when IBD patients taking azathioprine visit the hospital
Key secondary outcomes
The relationship between blood 6-TGN concentration, white blood cell count, and MCV when IBD patients taking azathioprine visit the hospital
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with IBD whom blood examination is necessary for the control of condition. All of the patients who undertaken azathioprine or tacrolimus can be the subjects of this study.
Key exclusion criteria
The patients who refuse to be subjects of this study and are judged as unfitness for the subject of this study by attending physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto prefectural university of medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL
075-723-6511
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Uchiyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL
075-723-6511
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization
Self funding
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
京都府立医科大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We have determined several SNPs of gene which is related to the risk ratio (defined as 6-TGN/dose of azathioprine).
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
Main results already published
Date of protocol fixation
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
In this study, there were no severe complication.
Management information
Registered date
| 2013 | Year | 03 | Month | 09 | Day |
Last modified on
| 2015 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011677
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
