UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035732 |
|---|---|
| Receipt number | 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 | 2020/10/23 18:31:12 |
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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
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
raito.asaoka@icloud.com
Sponsor or person
Institute
Department of gastrointestinal Surgery, Graduate School of Medicine, The university of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040705
