UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016229
Receipt number R000018832
Scientific Title Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer
Date of disclosure of the study information 2015/01/16
Last modified on 2017/10/23 21:58:12

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Basic information

Public title

Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer

Acronym

Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer

Scientific Title

Fusobacterium nucleatum in oral cavity and colon of patients with cororectal cancer

Scientific Title:Acronym

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

1st name
Middle name
Last name Shotaro Umezawa

Organization

Yokohama City University

Division name

Gastroenterology and Hepatorogy

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

umezawa-ykh@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shotaro Umezawa

Organization

Yokohama City University

Division name

Gastroenterology and Hepatorogy

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

umezawa-ykh@umin.ac.jp


Sponsor or person

Institute

Yokohama City University Gastroenterology and Hepatorogy

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2015 Year 01 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018832


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name