UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043553 |
|---|---|
| Receipt number | R000049734 |
| Scientific Title | The immunological, molecular biological and microbiological studies of small intestinal disease |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2023/07/09 22:53:29 |
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Basic information
Public title
The immunological, molecular biological and microbiological studies of small intestinal disease
Acronym
The immunological, molecular biological and microbiological studies of small intestinal disease
Scientific Title
The immunological, molecular biological and microbiological studies of small intestinal disease
Scientific Title:Acronym
The immunological, molecular biological and microbiological studies of small intestinal disease
Region
| Japan |
Condition
Condition
gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigate inflammatory and immune mechanisms by performing intestinal mucosal biopsy in patients with gastrointestinal diseases
Basic objectives2
Others
Basic objectives -Others
Elucidation of inflammatory and immune mechanisms
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elucidation of inflammatory and immune mechanisms
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 who are visiting or hospitalized at Keio University Hospital and have gastrointestinal disorders
And atients who need clinical intestinal mucosal (small intestine and large intestine) biopsy.
Further more, patients who have agreed to use the study.
For patients under 16 years of age, obtain parental consent.
Key exclusion criteria
Those who have impaired consciousness or mental symptoms and lack the ability to consent are not included in the subjects.
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Takabayashi |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0333531211
kaoru0902@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Anna |
| Middle name | |
| Last name | Tojo |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
0333531211
Homepage URL
anpanna.live.s.42@gmail.com
Sponsor or person
Institute
Keio University
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo
Tel
0333531211
anpanna.live.s.42@gmail.com
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
| 2021 | Year | 03 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Elucidation of inflammatory and immune mechanisms of intestinal diseases using biopsy of intestinal mucosa, blood, and feces
Management information
Registered date
| 2021 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049734
