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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009360
Receipt No. R000010999
Scientific Title The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Date of disclosure of the study information 2013/01/10
Last modified on 2016/11/14

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Basic information
Public title The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Acronym The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Scientific Title The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Scientific Title:Acronym The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate risk factors and appropriate follow-up period for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To assess risk factors for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Key secondary outcomes To assess the time of onset of metachronous gastric cancer after endoscopic treatment for early gastric cancer.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 The relationship of degree of gastric mucosal atrophy on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Interventions/Control_2 The relationship between successful H.pylori eradication arm and unsuccessful H.pylori eradication arm on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
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 after endoscopic treatment for early gastric cancer
Key exclusion criteria Patients after gastrectomy
Patinets without curative resection of gastric cancer endoscopically
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nonaka Takashi
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2640
Email nonaka_taka@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nonaka Takashi
Organization Yokohama City University Hospital
Division name Gastroenterology Division
Zip code
Address 3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2640
Homepage URL
Email nonaka_taka@yahoo.co.jp

Sponsor
Institute Gastroenterology Division, Yokohama City University Hospital
Institute
Department

Funding Source
Organization none
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
2013 Year 01 Month 10 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 Terminated
Date of protocol fixation
2013 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 19 Day
Last modified on
2016 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010999

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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