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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019935
Receipt No. R000023018
Scientific Title Changing trends and discrepancies of gastrointestinal neoplasms between two countries
Date of disclosure of the study information 2015/11/26
Last modified on 2018/09/05

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Basic information
Public title Changing trends and discrepancies of gastrointestinal neoplasms between two countries
Acronym Difference of gastrointestinal tumors in two countries
Scientific Title Changing trends and discrepancies of gastrointestinal neoplasms between two countries
Scientific Title:Acronym Difference of gastrointestinal tumors in two countries
Region
Japan Asia(except Japan)

Condition
Condition Early gastric cancer and colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Difference of early gastric cancer and colorectal cancer in two countries are analyzed
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The therapeutic results of early gastric cancer and colorectal cancer in two countries for 5 years
Key secondary outcomes The therapeutic results of early gastric cancer and colorectal cancer among elderly people in two countries

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases with endoscopic surgery or surgical operation for early gastric cancer or colorectal cancer in recent 5 years
Key exclusion criteria Cases with main organ dysfunction
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 65 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 975-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naohisa Yoshida
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 65 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5519
Homepage URL
Email naohisa@koto.kpu-m.ac.jp

Sponsor
Institute Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
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 YES
Study ID_1 KCT0001490
Org. issuing International ID_1 NIH
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都府立医科大学附属病院(京都府)、
Konkuk University School of Medicine, Seoul, Korea

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 26 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Difference of early gastric cancer and colorectal cancer in two countries in recent 5 years (2010-2014) are analyzed

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023018

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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