UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016228
Receipt number R000018155
Scientific Title Changes of intestinal bacterial flora in colon carcinogenesis
Date of disclosure of the study information 2015/12/11
Last modified on 2019/03/13 22:33:35

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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

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

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 or person

Institute

Yokohama City University Gastroenterology and Hepatorogy

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name