UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025528 |
|---|---|
| Receipt number | 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 | 2023/07/11 13:43:21 |
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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
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
High school students at first and second 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 | Tomohisa |
| Middle name | |
| Last name | Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Dept. of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5124
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Handa |
Organization
Kyoto Prefectural University of Medicine
Division name
Dept. of Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto
TEL
075-251-5519
Homepage URL
handao@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Source of Monetary Support:Department of Human Immunology and Nutrition Science, Kyoto Prefectur al University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine IRB
Address
465 Kajiicho, Kawaramachi-Hirokoji, Kamigyo, Kyoto
Tel
075-251-51111
rinri@koto.kpu-m.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
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、福知山市民病院、京都山城総合医療センター、京丹後市立久美浜病院、京都中部総合医療センター、綾部市立病院、京都府立医科大学附属北部医療センター、京都市立病院、岡田医院、舞鶴医療センター
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
5582
Results
In 2022, among 6551 high school student, 5582 students agreed to this project. Among them, 2.1% was positive for H. pylori infection. Among H. pylori positive students, eradication rate was 93.8%. In 2022, project is on going as scheduled.
Results date posted
| 2020 | Year | 07 | Month | 08 | Day |
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
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | 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
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
