UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023304 |
|---|---|
| Receipt number | R000026855 |
| Scientific Title | Exploratory research for markers of efficacy of treatment for inflammatory bowel disease |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/25 19:36:36 |
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Basic information
Public title
Exploratory research for markers of efficacy of treatment for inflammatory bowel disease
Acronym
Exploratory research for markers of efficacy of treatment for IBD
Scientific Title
Exploratory research for markers of efficacy of treatment for inflammatory bowel disease
Scientific Title:Acronym
Exploratory research for markers of efficacy of treatment for IBD
Region
| Japan |
Condition
Condition
Crohn's disease
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to explore markers of efficacy in remission-induction therapy for Inflammatory Bowel Disease (IBD--including Crohn's Disease and Ulcerative Colitis) by analyzing blood, stool, and bowel tissue biopsy samples from IBD patients pre- and post-treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To show a correlation between therapeutic response of the remission-induction therapy and biomarkers.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with IBD before remission induction therapy(regardless of a prior treatment)
Key exclusion criteria
1. patients with a history of bowel resection(exclude appendectomy)
2. patients during pregnancy and lactation
3. patients who wish to become pregnant
4. patients who have an abdominal infection including an abdominal abscess
5. patients during chemotherapy and immunosuppressant therapy
6. patients with a history of a malicnant disease
7. patients who are ruled unfit to this study by doctors
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kanai |
Organization
Keio University Hospital
Division name
Gastroenterology
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
03-5843-7090
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Yoshida |
Organization
Keio university hospital
Division name
Gastroenterology
Zip code
Address
35 Shinano-machi, Shinjuku-ku, Tokyo
TEL
03-5843-7090
Homepage URL
borg768@keio.jp
Sponsor or person
Institute
Keio university hospital, Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | 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
We explore markers of efficacy of the remission-induction therapy for inflammatory bowel diseases(IBD, including Crohn's disease and ulcerative colitis) by the analysis of samples(blood, stool, and biopsy form bowel tissue) taken from IBD patients before and after treatment.
Management information
Registered date
| 2016 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026855
| 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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