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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035483
Receipt No. R000040430
Scientific Title The study of long-term prognosis after endoscopic submucosal dissection for early gastric cancer in elderly patients with frailty
Date of disclosure of the study information 2019/01/08
Last modified on 2019/01/08

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Basic information
Public title The study of long-term prognosis after endoscopic submucosal dissection for early gastric cancer in elderly patients with frailty
Acronym The study of long-term prognosis after endoscopic submucosal dissection for early gastric cancer in elderly patients with frailty
Scientific Title The study of long-term prognosis after endoscopic submucosal dissection for early gastric cancer in elderly patients with frailty
Scientific Title:Acronym The study of long-term prognosis after endoscopic submucosal dissection for early gastric cancer in elderly patients with frailty
Region
Japan

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

Objectives
Narrative objectives1 To investigate long-term outcomes of elderly patients after ESD for EGC in frail patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3-year survival rate after gastric 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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients 80 years old and older who underwent ESD for the removal of gastric cancer between September 2008 and September 2014
Key exclusion criteria Patients who discontinued their follow-up within 3 years
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noboru Misawa
Organization Yokohama City University school of medicine
Division name Department of gastroenterology and hepatology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 0453707627
Email misawa-ykh@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Noboru Misawa
Organization Yokohama City University school of medicine
Division name Department of gastroenterology and hepatology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 0453707627
Homepage URL
Email misawa-ykh@umin.ac.jp

Sponsor
Institute Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
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
2019 Year 01 Month 08 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040430

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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