UMIN-CTR Clinical Trial

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
Last 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
1st 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