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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038569
Receipt No. R000043863
Scientific Title Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/13

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Basic information
Public title Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Acronym Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Scientific Title Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Scientific Title:Acronym Analysis of intestinal bacterial flora in adjuvant chemotherapy combined with oxaliplatin for stage III curatively resected colorectal cancer
Region
Japan

Condition
Condition Colon cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study analyzes the gut microbiota in patients who received adjuvant chemotherapy with oxaliplatin for stage III curatively resected colorectal cancer. The main objective is to examine how dysbiosis from adjuvant chemotherapy affects the patient's quality of life (QOL) and adverse event profile.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between changes in gut microbiota and side effects of chemotherapy.
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

Not applicable
Gender Male and Female
Key inclusion criteria A case of colon cancer histopathologically diagnosed as Stage III
Key exclusion criteria Patients under 20 years old
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yusaku
Middle name
Last name Watanabe
Organization Kawasaki Medical School
Division name Digestive Surgery
Zip code 701-0192
Address 577 Matsusima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Email yusakuwatanabe@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Yusaku
Middle name
Last name Watanabe
Organization Kawasaki Medical School
Division name Digestive Surgery
Zip code 701-0192
Address 577 Matsusima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email yusakuwatanabe@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Self sustaining
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 Kawasaki Medical School
Address 577 Matsusima, Kurashiki city, Okayama, Japan
Tel 086-462-1111
Email kenkyuhou@med.kawasaki-m.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 11 Month 13 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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