UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019864 |
|---|---|
| Receipt number | R000022949 |
| Scientific Title | Investigation of clinical usefulness of serum biomarker for patients with IBD. And analyse correlations between efficacy of GMA and serum biomarker. |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2016/11/20 15:37:54 |
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Basic information
Public title
Investigation of clinical usefulness of serum biomarker for patients with IBD.
And analyse correlations between efficacy of GMA and serum biomarker.
Acronym
Correlations between efficacy of GMA and serum biomarker for patients with IBD.
Scientific Title
Investigation of clinical usefulness of serum biomarker for patients with IBD.
And analyse correlations between efficacy of GMA and serum biomarker.
Scientific Title:Acronym
Correlations between efficacy of GMA and serum biomarker for patients with IBD.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Crohn's disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate of clinical usefulness of serum biomarker (MMP-9, etc.) for patients with IBD. And analyse correlations between efficacy of GMA and serum biomarker.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical response rate.
UC:Mayo score >= 30% decrease
partial Mayo score >= 30% decrease
CD:CDAI score >= 70 decrease
Key secondary outcomes
Clinical response rate.
UC:Mayo score <= 2
partial Mayo score<= 2
CD:CDAI score<= 150
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
1:Patient who judged that GMA treatment was appropriate along guidelines on Ministry of Health, Labour and Welfare.
2:Patient who are older than 20 years old.
3:Patiens who agreed to precipitate in this study after being informed of the study protocol.
Key exclusion criteria
1:Patient with granulocytopenia (granulocyte count < 2,000/mm3).
2:Patient with or suspected to have severe infection.
3:Patient who judged to be exclusive by investigators for a certain reason.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo,Bunkyo,Tokyo,JapanTokyo Japan
TEL
03-3813-3111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo,Bunkyo,Tokyo,JapanTokyo Japan
TEL
03-3813-3111
Homepage URL
otaro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
JIMRO Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The institute of medical science, the university of Tokyo
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
| 2016 | Year | 01 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the correlations between efficacy of GMA and serum biomarker at before and after treatment.
Design:cohort study
This study is conducted to the patients matching inclusion criteria from Jan.2016 to Oct.2017.
Management information
Registered date
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022949
| Research Plan | |
|---|---|
| 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 |
