UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019935
Receipt number 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 20:24:01

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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