UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043624 |
|---|---|
| Receipt number | R000049812 |
| Scientific Title | Analysis of cytokine and chemokine levels in human intestines |
| Date of disclosure of the study information | 2021/03/16 |
| Last modified on | 2023/09/25 12:21:09 |
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Basic information
Public title
Analysis of cytokine and chemokine levels in human intestines
Acronym
Analysis of cytokine and chemokine levels in human intestines
Scientific Title
Analysis of cytokine and chemokine levels in human intestines
Scientific Title:Acronym
Analysis of cytokine and chemokine levels in human intestines
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The gene expression of Cytokines and chemokines in human intestines is analyzed and compared them by the age.
Basic objectives2
Others
Basic objectives -Others
nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The mRNA expression levels of cytokines and chemokines in a part of normal intestines which removed surgically for several enteropathy.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
nothing
Key exclusion criteria
nothing
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Sayama |
Organization
Shizuoka University
Division name
Faculty of agriculture
Zip code
4228529
Address
836 Ohya, Suruga-ku, Shizuoka-city
TEL
+81542384865
sayama.kazutoshi@shizuoka.ac.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Sayama |
Organization
Shizuoka University
Division name
Faculty of agriculture
Zip code
4228529
Address
836 Ohya, Suruga-ku, Shizuoka-city
TEL
+81542384865
Homepage URL
sayama.kazutoshi@shizuoka.ac.jp
Sponsor or person
Institute
Shizuoka University
Institute
Department
Personal name
Funding Source
Organization
Shizuoka University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka University
Address
836 Ohya, Suruga-ku, Shizuoka-city
Tel
+81542384865
+81542384865
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 | 16 | 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
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The m-RNA is extracted from the normal tissue collected from the intestines which removed surgically for several enteropathy and the expression levels of cytokines and chemokines were analyzed.
Management information
Registered date
| 2021 | Year | 03 | Month | 16 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049812
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/09/25 | R6 UMIN提出用研究計画書（農学部 茶山）様式１.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/09/25 | 2019 同意説明文書・同意書(済生会病院との腸管関連の共同研究)（0620 茶山最終修正）.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/09/25 | ヒト腸管Sample管理表.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/49812
