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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036347
Receipt No. R000041402
Scientific Title Prospective observational study on intestinal microbiota and gene mutations and gene expressions in colorectal cancer and inflammatory bowel disease
Date of disclosure of the study information 2019/03/29
Last modified on 2019/03/29

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Basic information
Public title Prospective observational study on intestinal microbiota and gene mutations and gene expressions in colorectal cancer and inflammatory bowel disease
Acronym Prospective observational study on intestinal microbiota and gene mutations and gene expressions in colorectal cancer and inflammatory bowel disease
Scientific Title Prospective observational study on intestinal microbiota and gene mutations and gene expressions in colorectal cancer and inflammatory bowel disease
Scientific Title:Acronym Prospective observational study on intestinal microbiota and gene mutations and gene expressions in colorectal cancer and inflammatory bowel disease
Region
Japan

Condition
Condition colorectal cancer and inflammatory bowel disease
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to examine the association between intestinal microbiota and colorectal cancer and inflammatory bowel disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association of intestinal microbiota with gene mutations and gene expressions and clinicopathological factors in colorectal cancer and inflammatory bowel disease.
Key secondary outcomes

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 diagnosed colorectal cancer or inflammatory bowel disease by colonoscopy, computed tomography, and magnetic resonance imaging and scheduled to undergo surgery or colonoscopy.
#2 Age of patient is over 20 years old.
#3 Informed consent can be obtained.
Key exclusion criteria #1 Informed consent can not be obtained.
#2 Doctor recognizes that patient is not suitable for this study.
#3 Cases in which the lesion is very small and subsequent pathological diagnosis is considered difficult.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shozo
Middle name
Last name Yokoyama
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Email yokoyama@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Shozo
Middle name
Last name Yokoyama
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
TEL 073-441-0613
Homepage URL
Email yokoyama@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University, Second Department of Surgery
Institute
Department

Funding Source
Organization Wakayama Medical University, Second Department of Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kindai University School of Medicine, Department of Genome Biology
Wakayama Medical University, Second Department of Internal Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Independent ethics committee of Wakayama Medical University
Address 811-1 Kimiidera, Wakayama 641-8510 Japan
Tel 073-447-2300
Email wa-rinri@wakayama-med.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 03 Month 29 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
2017 Year 09 Month 05 Day
Date of IRB
2017 Year 09 Month 05 Day
Anticipated trial start date
2017 Year 09 Month 06 Day
Last follow-up date
2022 Year 09 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041402

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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