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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032115
Receipt No. 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 2019/04/19

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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
Email 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
Email ssue@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

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
Email 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
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
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
2019 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036636

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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