UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024240 |
|---|---|
| Receipt number | R000027813 |
| Scientific Title | Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with esophageal cancer |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2019/10/05 21:34:12 |
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Basic information
Public title
Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with esophageal cancer
Acronym
Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with esophageal cancer
Scientific Title
Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with esophageal cancer
Scientific Title:Acronym
Prospective study about the association between microbiota distribution and mucosal epithelium gene expression of patients with esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate distribution of the gastrointesitinal microbiota of intraoral tissue
,esophageal cancer tissue and esophageal normal tissue in this study
Basic objectives2
Others
Basic objectives -Others
Analysis of the gastrointestinal microbiota
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between gastrointesitinal microbiota of esophagial cancer tissue and esophagial normal tissue
Key secondary outcomes
The correlation between the variation of gastrointestinal microbiota and clinical condition (clinical stage,cerum inflammatory markers (CRP etc), PNI (prognostic nutritional index), performance status, BMI, cachectic presence, presence of sarcopenia) of esophagial cancer
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients of esophagial cancer
Key exclusion criteria
The patients whom doctor decided to be inadequate in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Uchiyama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
602-8566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5519
Homepage URL
k-uchi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji
Tel
0752515519
ayuka@koto.kpu-m.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
| 2016 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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 analyze the population of microbiota in the specimen using 16S rRNA meta genome analysis by a next-generation sequencer (MiSeq).
Management information
Registered date
| 2016 | Year | 09 | Month | 30 | Day |
Last modified on
| 2019 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027813
