UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032252
Receipt number R000036778
Scientific Title Association between colorectal cancer and bacterial flora
Date of disclosure of the study information 2018/04/16
Last modified on 2023/10/18 11:28:55

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Basic information

Public title

Association between colorectal cancer and bacterial flora

Acronym

Association between colorectal cancer and bacterial flora

Scientific Title

Association between colorectal cancer and bacterial flora

Scientific Title:Acronym

Association between colorectal cancer and bacterial flora

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the difference of bacterial flora between colorectal cancer, non-neoplastic tissue and feces

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

The difference between bacterial flora in colorectal cancer tissue and non-neoplastic tissue

Key secondary outcomes

1) The association between bacterial flora in colorectal cancer tissue and life style
2) The association between bacterial flora and location of colorectal cancer
3) The association between bacterial flora in colorectal cancer and prognosis
4) The association between bacterial flora in colorectal cancer and efficacy of chemotherapy


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with colorectal cancer of which primary lesion is resectable

Key exclusion criteria

Patients who meet any of the following conditions will be excluded
1) patients with colorectal cancer of which primary lesion is not large enough to get sample
2) patients who received emergency resection of primary lesion
3) patients who are judged unsuitable for this study by principal investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Toshifumi
Middle name
Last name Wakai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Digestive and General Surgery

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

TEL

025-227-2228

Email

wakait@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Yosuke
Middle name
Last name Tajima

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

TEL

090-4756-9309

Homepage URL


Email

y-tajima@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Ministry of education

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Yasuda Yogurt Co., Ltd.
Bourbon Corporation

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan

Tel

0252282565

Email

ethics@adm.niigata-u.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

新潟大学大学院医歯学総合研究科(新潟県)


Other administrative information

Date of disclosure of the study information

2018 Year 04 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

10

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

No longer recruiting

Date of protocol fixation

2018 Year 04 Month 15 Day

Date of IRB

2018 Year 01 Month 25 Day

Anticipated trial start date

2018 Year 04 Month 16 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the difference of bacterial flora between colorectal cancer, non-neoplastic tissue and feces with 16S rRNA metagenomic analysis


Management information

Registered date

2018 Year 04 Month 14 Day

Last modified on

2023 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name