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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024239
Receipt No. R000027811
Scientific Title Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with gastric and colorectal cancer
Date of disclosure of the study information 2016/11/01
Last modified on 2019/10/05

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Basic information
Public title Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with gastric and colorectal cancer
Acronym Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with gastric and colorectal cancer
Scientific Title Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with gastric and colorectal cancer
Scientific Title:Acronym Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with gastric and colorectal cancer
Region
Japan

Condition
Condition Gastric cancer and colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will investigate distribution of the gastrointesitinal microbiota of gastriccolorectal cancer tissue and gastric and colorectal normal tissue in this study
Basic objectives2 Others
Basic objectives -Others Analysis of the gastrointestinal microbiota
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The difference between gastrointesitinal microbiota of cancer tissue and normal tissue of gastric and colorectal normal tissue
Key secondary outcomes The correlation between the variation of gastrointestinal microbiota and clinical condition (clinical stage,cerum inflammatory markers (CRP etc), PNI (prognostic nutritional index), performance status, BMI, cachectic presence, presence of sarcopenia) of gastric and colorectal cancer

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 The patients of gastric cancer and colorectal cancer
Key exclusion criteria The patients whom doctor decided to be inadequate in this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 602-8566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kazuhiko
Middle name
Last name Uchiyama
Organization Kyoto Prefectural University of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 602-8566
Address 465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Homepage URL
Email k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization apan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine
Address 465, Kajii-cho, Kawaramachi-Hirokoji
Tel 0752515519
Email hkitae@koto.kpu-m.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
2016 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We analyze the population of microbiota in the specimen using 16S rRNA meta genome analysis by a next-generation sequencer (MiSeq).

Management information
Registered date
2016 Year 09 Month 30 Day
Last modified on
2019 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027811

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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