UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between colorectal tumor and bowel gas compound
Acronym	The relationship between colorectal tumor and bowel gas compound
Scientific Title	The relationship between colorectal tumor and bowel gas compound
Scientific Title:Acronym	The relationship between colorectal tumor and bowel gas compound
Region	Japan

Condition
Condition	colorectal tumor
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analysis the gas compounds from flatus of colorectal cancer,polyp and healthy controls
Basic objectives2	Others
Basic objectives -Others	To analysis the gas component from flatus of colorectal cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between gas component in colorectal cancer patients and healthy controls.
Key secondary outcomes	1.Correlation between gas component in colorectal polyp patients and healthy controls. 2.Correlation between gas component in colon cancer and polyp patients. 3.Colorectal cancer nomogram by gas component. 4.Differences between preoperative and postoperative gas component

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	a. Healthy control 1.No colorectal polyp in colonoscopy within the past 5 years. 2.No polypectomy or EMR for colorectal polyp within the past 5 years. 3. Written informed consent. b.Colorectal polyp patient 1.Colorectal polyp 2.Written informed consent. c.Colorectal cancer patient 1.Colorectal cancer 2.Written informed consent.
Key exclusion criteria	1.Colorectal cancer in past history 2.Infectious enteritis 3.Inframmatory bowel disease 4.Bowel obstruction 5.Other inappropriate patient
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name ISHIBE
Organization	Yokohama City University
Division name	Gastroenterological surgery
Zip code	2360004
Address	Fukuura 3-9, Kanazawa-ku, Yokohama City, KANAGAWA
TEL	045-787-2650
Email	aishibe@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Atushi Middle name Last name ISHIBE
Organization	Yokohama City University
Division name	Gastroenterological surgery
Zip code	2360004
Address	Fukuura 3-9, Kanazawa-ku, Yokohama City, KANAGAWA
TEL	045-787-2650
Homepage URL
Email	aishibe@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University , Gastroenterological surgery
Institute
Department

Funding Source
Organization	Japan society for the promation of science
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	Yokohama City University
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City, KANAGAWA
Tel	045-370-7627
Email	rinri@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	横浜市立大学附属病院（神奈川県） 横浜市立大学附属市民総合医療センター（神奈川県） 港北肛門クリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 21 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	2018 Year 11 Month 25 Day
Date of IRB	2018 Year 09 Month 20 Day
Anticipated trial start date	2018 Year 12 Month 21 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Measure the gas component from flatus of the subject at home for one week.

Management information
Registered date	2018 Year 12 Month 21 Day
Last modified on	2021 Year 05 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040265