UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013761 |
|---|---|
| Receipt number | R000016049 |
| Scientific Title | Effects of chronic Helicobacter pylori infection upon systemic organs |
| Date of disclosure of the study information | 2014/04/19 |
| Last modified on | 2024/01/05 09:46:25 |
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Basic information
Public title
Effects of chronic Helicobacter pylori infection upon systemic organs
Acronym
Effects of H. pylori on systemic organs
Scientific Title
Effects of chronic Helicobacter pylori infection upon systemic organs
Scientific Title:Acronym
Effects of H. pylori on systemic organs
Region
| Japan |
Condition
Condition
Disorders of systemic organs
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Hematology and clinical oncology | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to elucidate various effects of chronic Helicobacter pylori infection upon various systemic disoders, using the large-scale data of healthy subjects.
Basic objectives2
Others
Basic objectives -Others
etiological influences
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of various disorders of systemic organs
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The study population was the subjects who received medical checkup at Kameda Medical Center Makuhari (Chiba-shi, Chiba, Japan) in 2010, approved their entry to our study, were not less than 20 years old, and answered to the questionnaire.
Key exclusion criteria
age less than 20 years and insufficient answers to the questionnaire
Target sample size
21000
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Yamamichi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
nyamamic-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobutake |
| Middle name | |
| Last name | Yamamichi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3815-5411
Homepage URL
nyamamic-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
a grant from Chiyoda Mutual Life Foundation, the Shimabara Science Promotion Foundation, St. Luke's Life Science Institute, and the Daiwa Security Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee / Human Genome, Gene Analysis Research Ethics Committee of the Faculty of Medicine and Graduate School of Medicine of the Univ of Tokyo, and the Univ of Tokyo hospital
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
0338155411
ethics@m.u-tokyo.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
| 2014 | Year | 04 | Month | 19 | 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
20773
Results
Takeuchi C, Yamamichi N, et al.
Gastric Cancer. 2017; 20(2):314-321.
Yamamichi N, et al.
PLoS One. 2015; 10(4):e0123688.
Takahashi Y, Yamamichi N, et al.
J Gastroenterol. 2014; 49(5):882-9.
Yamamichi N, Hirano C, et al.
PLoS One. 2014; 9(10):e111359.
Yamamichi N, et al.
PLoS One. 2014; 9(2):e88277.
Minatsuki C, Yamamichi N, , et al.
PLoS One. 2013; 8(7):e69891.
Shimamoto T, Yamamichi N, , et al.
PLoS One. 2013; 8(6):e65996.
Yamamichi N, Mochizuki S, , et al.
BMC Med. 2012; 10:45.
Results date posted
| 2019 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data of all the study participants are continually accumulated.
Management information
Registered date
| 2014 | Year | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016049
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
