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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026480
Receipt No. R000030414
Scientific Title Safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Date of disclosure of the study information 2017/03/09
Last modified on 2017/03/09

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Basic information
Public title Safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Acronym Safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Scientific Title Safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Scientific Title:Acronym Safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify safety and long-term prognosis of endoscopic submucosal dissection for early gastric cancer in elderly patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 5-year overall aurvival of early gastric cancer after ESD
Key secondary outcomes

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 patients diagnosed as early gastric cancer before ESD
Key exclusion criteria Patients whom a researcher judged to be inappropriate as a subject.
Target sample size 598

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 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Dohi
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-251-5519
Homepage URL
Email osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization 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 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
2017 Year 03 Month 09 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
2017 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical information was reviewed retrospectively.

Management information
Registered date
2017 Year 03 Month 09 Day
Last modified on
2017 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030414

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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