UMIN-CTR Clinical Trial

Basic information
Public title	The effect of gut microbiota on the response to neoadjuvant DCF therapy for locally advanced esophageal cancer: A single center prospective study
Acronym	The effect of gut microbiota on the response to neoadjuvant DCF therapy for locally advanced esophageal cancer: A single center prospective study
Scientific Title	The effect of gut microbiota on the response to neoadjuvant DCF therapy for locally advanced esophageal cancer: A single center prospective study
Scientific Title:Acronym	The effect of gut microbiota on the response to neoadjuvant DCF therapy for locally advanced esophageal cancer: A single center prospective study
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to predict the response to the neoadjuvantchemotherapy by analyzing fecal microbiota of the patients with clinical stage II or III esophageal cancer.
Basic objectives2	Others
Basic objectives -Others	The other aim of this study is to investigate the difference of microbiota between patients who sufferd adverse effects (diarrhea, febrile neutropenia) and patients who did not suffer them.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the transition of the microbiota of the patients during neoadjuvant chemotherapy.(before chemotherapy and after chemotherapy)
Key secondary outcomes	a. the difference of microbiota between patients who responded well to chemotherapy and patients who did not respond. b.the difference of microbiota between patients who sufferd adverse effects and patients who did not suffer them.

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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1)undergoing neoadjuvant chemotherapy (2)curative intent surgery can be performed
Key exclusion criteria	(1)unable to join due to his/her mental status or metal disorder (2)attending doctors judge him/her to be inappropriate to join in this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuyuki Seto
Organization	Graduate School of Medicine, The university of Tokyo
Division name	Department of gastrointestinal Surgery
Zip code
Address	7-3-1, Hongou, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Raito Asaoka
Organization	Graduate School of Medicine, The university of Tokyo
Division name	Department of gastrointestinal Surgery
Zip code
Address	7-3-1, Hongou, Bunkyo-ku, Tokyo
TEL	+81-3-3815-5411
Homepage URL
Email	raito.asaoka@icloud.com

Sponsor
Institute	Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Institute
Department

Funding Source
Organization	Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
Email

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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 02 Month 07 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	2018 Year 12 Month 07 Day
Date of IRB	2019 Year 01 Month 25 Day
Anticipated trial start date	2019 Year 02 Month 01 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will analyze the change of microbiota of the patients who undergo neoadjuvant chemotherapy for advanced esophageal cancer.

Management information
Registered date	2019 Year 01 Month 31 Day
Last modified on	2020 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040705