UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021176 |
|---|---|
| Receipt number | R000023180 |
| Scientific Title | Association between inflammatory bowel disease and cellular stress response |
| Date of disclosure of the study information | 2016/02/25 |
| Last modified on | 2022/05/24 21:11:20 |
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Basic information
Public title
Association between inflammatory bowel disease and cellular stress response
Acronym
IBD and celluar stress response
Scientific Title
Association between inflammatory bowel disease and cellular stress response
Scientific Title:Acronym
IBD and celluar stress response
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the association between inflammatory bowel disease and cellular stress response
Basic objectives2
Others
Basic objectives -Others
To assess pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The assciation betwen activity of inflammatory bowel disease and cellular stress response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Divided into groups by clinical diagnoses
Interventions/Control_2
Biopsies during colonoscopy
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. Patients who underwent colonoscopy within 3 years
2. Patients who are going to undergo colonoscopy
3. Patients with inflammatory bowel disease (Ulcerative colitis or Crohn's disease) or patients who undergo colonoscopy
Key exclusion criteria
1.Biopsy cannnot be performed
2.Colonoscopy cannot be performed (shown below)
a. patients with difficulty of colonoscopy
b. patients with active bleeding
c. patients with instability of circulation and breathing
d. patients who cannot take bowel preparation
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-19-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
shikokuri@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-19-15 Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8137
Homepage URL
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
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
Gunma University Hospital Institutional Review Board
Address
3-39-15 Showa-machi Maebashi, Gunma, Japan
Tel
027-220-8740
shikokuri@gunma-u.ac.jp
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 | 02 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023180
| 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 |
