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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035732
Receipt No. R000040705
Scientific Title The effect of gut microbiota on the response to neoadjuvant DCF therapy for locally advanced esophageal cancer: A single center prospective study
Date of disclosure of the study information 2019/02/07
Last modified on 2019/01/31

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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
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
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
Name of secondary funder(s)

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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
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
2019 Year 01 Month 31 Day


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

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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