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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001169
Receipt No. R000001433
Scientific Title study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer
Date of disclosure of the study information 2008/05/31
Last modified on 2008/05/31

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Basic information
Public title study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer
Acronym JGSG secondary gastric cancer study
Scientific Title study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer
Scientific Title:Acronym JGSG secondary gastric cancer study
Region
Japan

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

Objectives
Narrative objectives1 To evaluate inhibitory effects of H. pylori eradication on the development of metachronous gastric carcinomas after endoscopic resection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Detection of secondary (metachronous) cancer at another site of the stomach
Key secondary outcomes Recurrence of residual cancer at the resection site because of incomplete resection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 H. pylori eradication
Interventions/Control_2 No eradication
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients eligible for enrollment included those diagnosed with early gastric cancer, either newly diagnosed and planning to have endoscopic treatment or those in whom early gastric cancer had been resected and were in follow-up phase after endoscopic treatment.
Key exclusion criteria Exclusion criteria were absence of an active H. pylori infection; development of another gastric cancer after endoscopic treatment prior to entry; and a history of gastric surgery.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Asaka
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address North 15, West 7, Kita-Ku, Sapporo, Hokkaido, JAPAN
TEL 011-716-1161
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mototsugu Kato
Organization Hokkaido University Hospital
Division name Division of endoscopy
Zip code
Address North 14, West 5, Kita-Ku, Sapporo, Hokkaido, JAPAN
TEL 011-716-1161
Homepage URL http://www.jgsg.jp/
Email m-kato@med.hokudai.ac.jp

Sponsor
Institute Japan Gast Study Group
Institute
Department

Funding Source
Organization Hiroshima Cancer Seminar Foundation.
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2008 Year 05 Month 31 Day

Related information
URL releasing protocol http://www.jgsg.jp/
Publication of results Partially published

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
2000 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2001 Year 04 Month 01 Day
Last follow-up date
2006 Year 08 Month 01 Day
Date of closure to data entry
2006 Year 09 Month 01 Day
Date trial data considered complete
2006 Year 09 Month 01 Day
Date analysis concluded
2006 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 31 Day
Last modified on
2008 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001433

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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