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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038703
Receipt No. R000044125
Scientific Title Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Date of disclosure of the study information 2019/11/30
Last modified on 2019/11/27

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Basic information
Public title Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Acronym Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Scientific Title Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Scientific Title:Acronym Gut microbiome of gastroenterological cancer: An exhaustive prospective cohort study
Region
Japan

Condition
Condition Gastroenterological cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To analyze the association between gut microbiome and prognosis in gastroenterological cancer.
Basic objectives2 Others
Basic objectives -Others To analyze the association between gut microbiome and prognosis in gastroenterological cancer.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To estimate 5-year overall survival in the difference of gut microbiome in gastroenterological cancer.
Key secondary outcomes comparison of gut microbiome between tumor site and non-tumor site.
comparison of metaborome between tumor site and non-tumor site.
comparison of distribution of gut microbiome between before treatment and after treatment.

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 over 20-year-old
confirming gastroenterological cancer pathologically
patients were recieved informed consent
Key exclusion criteria judgement not to register suitably
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Itaru
Middle name
Last name Endo
Organization Yokohama city university school of medicine
Division name Department of gastroenterological surgery
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 0457872650
Email t196956a@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Midori
Middle name
Last name Tominaga
Organization Yokohama city university
Division name Y-NEXT
Zip code 2360004
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 0457872650
Homepage URL
Email ynext@yokohama-cu.ac.jp

Sponsor
Institute Yokohama city university
Institute
Department

Funding Source
Organization no funding source
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama city university
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
Tel 0457872650
Email ynext@yokohama-cu.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
2019 Year 11 Month 30 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 07 Day
Date of IRB
2019 Year 08 Month 23 Day
Anticipated trial start date
2019 Year 10 Month 17 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
2027 Year 03 Month 31 Day

Other
Other related information Compared the difference of gut microbiome and metaborome between tumor site and non-tumor site, follow the prognosis.

Management information
Registered date
2019 Year 11 Month 27 Day
Last modified on
2019 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044125

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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