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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025528
Receipt No. R000029381
Scientific Title Multi-center prospective "test and treat" study on Helicobacter pylori for high school students in Kyoto Prefecture.
Date of disclosure of the study information 2017/01/05
Last modified on 2018/07/09

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Basic information
Public title Multi-center prospective "test and treat" study on Helicobacter pylori for high school students in Kyoto Prefecture.
Acronym Kyoto HP project for high school students.
Scientific Title Multi-center prospective "test and treat" study on Helicobacter pylori for high school students in Kyoto Prefecture.
Scientific Title:Acronym Kyoto HP project for high school students.
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of infection rate, and the safeness and efficacy of Helicobacter pylori in high school students.
Basic objectives2 Others
Basic objectives -Others The preventive effect of Helicobacter pylori eradication therapy on gastric carcinogenesis.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Infection rate, and side effect and eradication rate of Helicobacter pylori
Key secondary outcomes Suppressive effect of Helicobacter pylori eradication therapy on gastric carcinogenesis.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Eradication for Helicobacter pylori (PAM7days)
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
15 years-old <=
Age-upper limit
16 years-old >=
Gender Male and Female
Key inclusion criteria High school students at first grade in Kyoto Prefecture
Key exclusion criteria 1.Not agreed to the study
2.When the examining physician judges that she/he is not adequate for the study
Target sample size 24000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Dept. of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Handa
Organization Kyoto Prefectural University of Medicine
Division name Dept. of Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL 075-251-5519
Homepage URL
Email handao@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 JCHO鞍馬口医療センター、京都第一赤十字病院、大津市民病院、松下記念病院、済生会京都府病院、宇治武田病院、康生会武田病院、医仁会総合武田病院、西陣病院、洛和会音和病院、福知山市民病院、学研都市病院、京都山城総合医療センター、安藤クリニック、粉川内科医院 

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Fifteen high school agreed to this project. Nineteen fifty five students out of 3263 students at first grade agreed to the examination and 78 students were Helicobacter pylori positive. And eradication therapy is on going. In 2018, 30 high school will agree to this project.
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
2014 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 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
2017 Year 01 Month 04 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029381

Research Plan
Registered date File name
2018/01/09 01 研究計画書.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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