UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The novel diagnostic method of colorectal cancer by methyl mercaptan
Title of the study (Brief title)	The novel diagnostic method of colorectal cancer by methyl mercaptan
Region	Japan

Condition
Condition	The novel diagnostic method for colorectal cancer: Detection of methyl-mercaptan from flatus.
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 patients and healthy controls to identify colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	To analysis correlation between colon cancer and each gas from flatus
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the amount of methylmercaptan from flatus
Key secondary outcomes	the amount of CO2, H2, H2S, CH4 from flatus Correlation between colon cancer and each gas

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)Colorectal cancer 2)Written informed consent.
Key exclusion criteria	1)Infectious enteritis 2)Inframmatory bowel disease 3)Bowel obstruction
Target sample size	50

Research contact person
Name of lead principal investigator	Atsushi Ishibe
Organization	Yokohama City University
Division name	Department of Gastroenterological surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	0457872650
Email	aishibe@yokohama-cu.ac.jp

Public contact
Name of contact person	Atsushi Ishibe
Organization	Yokohama City University
Division name	Department of Gastroenterological surgery
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	0457872650
Homepage URL
Email	aishibe@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2017 Year 07 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Everyone who met the selection criteria in patients who visited our institusion

Management information
Registered date	2017 Year 07 Month 16 Day
Last modified on	2018 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021770