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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014172
Receipt No. R000016496
Scientific Title Study of the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Date of disclosure of the study information 2014/06/10
Last modified on 2014/06/05

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Basic information
Public title Study of the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Acronym Study of the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Scientific Title Study of the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Scientific Title:Acronym Study of the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Region
Japan

Condition
Condition Junior and senior high school students who had anti-H.pylori antibody test in urine.
Classification by specialty
Gastroenterology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the accuracy of urinary anti-H.pylori antibody test for junior and senior high school students
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Compare urinary anti-H.pylori antibody test with urea breath test as a standard.
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
12 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Junior or senior high school students who had urinary anti-H. pylori antibody test and showed consents with document for this study.
Key exclusion criteria Students who meet any of following conditions will be excluded.
1)Students who show severe proteinuria or renal dysfunction.
2)Students who had eradication therapy to H. pylori.
3)Students who show severe hematuria or contain blood by menstruation.
4)Students who had antibiotics or PPI within 2 weeks.
5)Students who is judged unsuitable for this study by principal investigator.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Fukuda
Organization Hyogo College of Medicine
Division name Department of General Medicine and Community Health Science
Zip code
Address Kuro-oka 5, Sasayama Hyogo
TEL 079-552-1181
Email cdhpyf@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masumi Okuda
Organization Hyogo College of Medicine
Division name Department of General Medicine and Community Health Science
Zip code
Address Kuro-oka 5, Sasayama Hyogo
TEL 079-552-1181
Homepage URL
Email okuda@naxnet.or.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization JAPANGAST Study Group
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 10 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 Open public recruiting
Date of protocol fixation
2014 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective and random-sampling

Management information
Registered date
2014 Year 06 Month 05 Day
Last modified on
2014 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016496

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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