UMIN-CTR Clinical Trial

Basic information
Public title	Clarification of gut microbiota in patients with esophageal cancer closely related to a life style.
Acronym	Clarification of gut microbiota in patients with esophageal cancer.
Scientific Title	Clarification of gut microbiota in patients with esophageal cancer closely related to a life style.
Scientific Title:Acronym	Clarification of gut microbiota in patients with esophageal cancer.
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify of dysbiosis in patients with esophageal cancer closely related to a life style and investigate causal relationship between gut microbiota and preoperative chemoradiation therapy or surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The characteristics of gut microbiota in patient with esophageal cancer The effect of chemoradiation therapy and surgery on gut microbiota in patient with esophageal cancer
Key secondary outcomes	Correlation with gut microbiota and surgical outcome, survival, clinical findings, blood biochemistry finding and presence of gastrointestinal symptoms

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	1) The patients who are diagnosed esophageal cancer and planned to be treated in Kyusyu University Hospital or Fukuoka Dental College Hospital 2) The person who understand the details of the study and have the ability to provide informed consent
Key exclusion criteria	1) The patients who are pregnant or may be pregnant 2) The patients with psychiatric disorders. 3) The patients who are judged that participation in the study is inadequate by the medical attendant
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomoharu Middle name Last name Yoshizumi
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Zip code	812-8582
Address	3-1-1, Maidashi, Higashiku, Fukuoka city, Fukuoka, Japan
TEL	092-642-5462
Email	yosizumi@surg2.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Hasuda
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Science
Zip code	812-8582
Address	3-1-1, Maidashi, Higashiku, Fukuoka city, Fukuoka, Japan
TEL	092-642-5466
Homepage URL
Email	h-hasuda@surg2.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Fukuoka Dental College Hospital Biofermin Pharmaceutical Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Kyushu University
Address	3-1-1, Maidashi, Higashiku, Fukuoka city, Fukuoka, Japan
Tel	092-642-5774
Email	ijkseimei@jimu.kyushu-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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 31 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	Completed
Date of protocol fixation	2019 Year 01 Month 28 Day
Date of IRB	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 01 Month 28 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	[Study design] Prospective observational study [Recruitment of target people] During the experimental period, the person who are planned to be treated in Kyusyu University Hospital or Fukuoka Dental College Hospital, satisfy selection criteria and write informed consent to participate in this study. [measurement item] Gut microbiota

Management information
Registered date	2019 Year 05 Month 29 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042029