UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036882 |
|---|---|
| Receipt number | R000042029 |
| Scientific Title | Clarification of gut microbiota in patients with esophageal cancer closely related to a life style. |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/05/07 11:41:26 |
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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
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
h-hasuda@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042029
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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