UMIN-CTR Clinical Trial

Basic information
Public title	Changes of intestinal bacterial flora in colon carcinogenesis
Acronym	Changes of intestinal bacterial flora in colon carcinogenesis
Scientific Title	Changes of intestinal bacterial flora in colon carcinogenesis
Scientific Title:Acronym	Changes of intestinal bacterial flora in colon carcinogenesis
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the difference of bacterial flora between colon cancer, adenoma and nomal mucosa in patietns with colon cancer.
Basic objectives2	Others
Basic objectives -Others	To isolate the bacteria which is significantly rich in cancer lesion
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of bacterial flora between colon cancer, adenoma and nomal mucosa
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	patient present with colorectal cancer subject without colorectal tumor as controls
Key exclusion criteria	1 patient with inflammatory bowel disease or any other disease of bowel inflammation 2 history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 3 history of abnormal blood clotting 4 risk of complication of biopsy due to antiplatelet drug or anticoanrants 5 patients who we can not get written informed consent from 6 patients judged as being inappropriate candidates for the trial by the investigators
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama city university school of medicine
Division name	Gastroenterology and Hepatorogy
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	umezawa-ykh@umin.ac.jp

Public contact
1st name of contact person	1st name Takuma Middle name Last name Higurashi
Organization	Yokohama City University
Division name	Gastroenterology and Hepatorogy
Zip code	236-0004
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	takuma_h@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Gastroenterology and Hepatorogy
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Hospital IRB
Address	3-9 Fukuura Kanazawa-ku Yokohama City
Tel	81-45-787-2640
Email	takuma_h@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

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 11 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	2014 Year 12 Month 11 Day
Date of IRB	2014 Year 11 Month 30 Day
Anticipated trial start date	2014 Year 12 Month 12 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective case-control sampling

Management information
Registered date	2015 Year 01 Month 16 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018155