UMIN-CTR Clinical Trial

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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