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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039081
Receipt No. R000044222
Scientific Title Gut microbiota and colorectal tumor
Date of disclosure of the study information 2020/01/09
Last modified on 2020/01/08

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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
Email 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
Email kozue2011@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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