UMIN-CTR Clinical Trial

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
Email	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
Email	k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027813