UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039081 |
|---|---|
| Receipt number | R000044222 |
| Scientific Title | Gut microbiota and colorectal tumor |
| Date of disclosure of the study information | 2020/01/09 |
| Last modified on | 2023/01/11 10:37:48 |
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Basic information
Public title
Gut microbiota and colorectal tumor
Acronym
Gut microbiota and colorectal tumor
Scientific Title
Gut microbiota and colorectal tumor
Scientific Title:Acronym
Gut microbiota and colorectal tumor
Region
| Japan |
Condition
Condition
colorectal cancer
FAP
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to make clear the effect of microbiota on colon carcinogenesis by analyzing noot only sporadic colorectal cancer but also hereditary colorectal cancer : familial adenomatous polyposis and Lynch syndrome.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
gut microbiota analysis
Key secondary outcomes
mouse experiments with isolated bacterium from patients
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. Patients receiving colorectal cancer treatment.
2. Patients with high risk of colorectal cancer who undergo endoscopy / treatment.
Key exclusion criteria
1. Patients for whom consent was not obtained.
2. Patients with serious infections.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Honda |
Organization
Keio University School of Medicine
Division name
Department of Microbiology and Immunology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582, Japan
TEL
03-5363-3769
kenya@keio.jp
Public contact
Name of contact person
| 1st name | Kozue |
| Middle name | |
| Last name | Takeshita |
Organization
Keio University School of Medicine
Division name
Department of Microbiology and Immunology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582, Japan
TEL
03-5363-3769
Homepage URL
kozue2011@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JST
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
Keio Medical School Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku Tokyo 160-8582, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2020 | Year | 01 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2023 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044222
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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