UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032115 |
|---|---|
| Receipt number | R000036636 |
| Scientific Title | Urine Helicobacter pylori enzyme-linked immunosorbent assay for university students at the health examination and questionnaire based survey |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2020/03/18 17:10:47 |
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Basic information
Public title
Urine Helicobacter pylori enzyme-linked immunosorbent assay for university students at the health examination and questionnaire based survey
Acronym
Urine HP test and questionnaire for university students
Scientific Title
Urine Helicobacter pylori enzyme-linked immunosorbent assay for university students at the health examination and questionnaire based survey
Scientific Title:Acronym
Urine HP test and questionnaire for university students
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the usability of Urine Helicobacter pylori enzyme-linked immunosorbent assay for university student at the health examination.
To conduct a survey of awareness to Helicobacter pylori test at the health examination on university student.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of Urine Helicobacter pylori enzyme-linked immunosorbent assay for university student at the health examination.
Key secondary outcomes
(1)Implementation rate of the test, Rate which has received the result answer the questionnaire
(2)The survey of awareness to Helicobacter pylori test at the health examination on university student
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) First-year University student of Yokohama City University and Yokohama National University at 2018 (n=3185).
(2) Student who submit a urine for health examination.
(3) Student who give a written informed consent.
Key exclusion criteria
No exclusion.
Target sample size
3185
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Maeda |
Organization
Yokohama City University
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-787-2326
smaeda@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Sue |
Organization
Yokohama City University
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-787-2326
Homepage URL
ssue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefecture, Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics committee
Address
Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
Tel
045-370-7627
rinri@yokohama-cu.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
| 2018 | Year | 04 | Month | 05 | 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
2436
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
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items:
(1) Positive rate of Urine Helicobacter pylori enzyme-linked immunosorbent assay (u-HpELISA) for University Students.
(2) Implementation rate of u-HpELISA, the rate who has received result answer the questionnaire.
(3) The survey of awareness about Helicobacter pylori test at the health examination on university student.
Management information
Registered date
| 2018 | Year | 04 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036636
| Research Plan | |
|---|---|
| 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 |
