UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032252
Receipt No. R000036778
Scientific Title Association between colorectal cancer and bacterial flora
Date of disclosure of the study information 2018/04/16
Last modified on 2019/09/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Niigata University
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2019 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.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


Contact us.