UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer
Title of the study (Brief title)	Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer
Region	Japan

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

Objectives
Narrative objectives1	to clarify the homology of Fusobacterium nucleatum in oral cavity and colon of colorectal cancer
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the homology of Fusobacterium nucleatum in oral cavity and colon
Key secondary outcomes	the homology of Fusobacterium nucleatum in colorectal cancer patients and healthy controls

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
Name of lead principal investigator	Shotaro Umezawa
Organization	Yokohama City University
Division name	Gastroenterology and Hepatorogy
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	umezawa-ykh@umin.ac.jp

Public contact
Name of contact person	Shotaro Umezawa
Organization	Yokohama City University
Division name	Gastroenterology and Hepatorogy
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Homepage URL
Email	umezawa-ykh@umin.ac.jp

Sponsor
Institute	Yokohama City University Gastroenterology and Hepatorogy
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	2015 Year 01 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 16 Day
Anticipated trial start date	2015 Year 01 Month 16 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	prospective case-control sampling

Management information
Registered date	2015 Year 01 Month 16 Day
Last modified on	2017 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018832