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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020280
Receipt No. R000023413
Scientific Title Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study
Date of disclosure of the study information 2015/12/19
Last modified on 2019/12/23

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Basic information
Public title Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study
Acronym A prospective study of H.pylori prevalence and spontaneous eradication in patients for gastrectomy
Scientific Title Investigation of H.pylori prevalence and its spontaneous eradication rate in gastric cancer patients for gastrectomy: A prospective study
Scientific Title:Acronym A prospective study of H.pylori prevalence and spontaneous eradication in patients for gastrectomy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the prevalence of H.pylori in gastric cancer patients and its spontaneous eradication rate after gastrectomy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Spontaneous eradication rate of H. pylori one year after gastrectomy
Key secondary outcomes Prevalence of H. pylori before gastrectomy, Overall survival, Relapse free survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 H.pylori test before gastrectomy and follow-up one year after gastrectomy for H. pylori positive patients
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 1)Pathologically diagnosed as primary gastric adenocarcinoma
2)Planed to complete resection by distal gastrectomy or proximal gastrectomy
3)20 years old or older at the enrollment
4)Document of agreement with eorollment in person
Key exclusion criteria 1)History of gastrectomy
2)Histry of H. pylori treatment
3)Case judged as ineligible by attending physicia
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Doki
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2, Yamadaoka, Suita, Osaka
TEL +81-6-6879-3251
Email ydoki@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Yukinori
Middle name
Last name Kurokawa
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code 565-0871
Address 2-2-E2, Yamadaoka, Suita, Osaka
TEL 81-6-6879-3251
Homepage URL
Email ykurokawa@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Clinical Study Group of Osaka University
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 Osaka University Hospital Institutional Review Board
Address 2-15, Yamadaoka, Suita, Osaka
Tel 81-6-6210-8289
Email rinri@hp-crc.med.osaka-u.ac.jp

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
2015 Year 12 Month 19 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 1265
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 No longer recruiting
Date of protocol fixation
2015 Year 11 Month 07 Day
Date of IRB
2015 Year 12 Month 24 Day
Anticipated trial start date
2016 Year 01 Month 04 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 19 Day
Last modified on
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023413

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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