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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016929
Receipt No. R000019654
Scientific Title Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Date of disclosure of the study information 2015/03/27
Last modified on 2019/01/14

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Basic information
Public title Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Acronym Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Scientific Title Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Scientific Title:Acronym Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Region
Japan

Condition
Condition Junior high school students who had anti-H.pylori antibody test in urine.
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior 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 urine antibody test and stool antigen test for H. pylori infection.
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 who had urinary anti-H. pylori antibody test and showed consents with document for this study.
Key exclusion criteria Students or their parents refuse the entry to this registry.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chika Kusano
Organization Nihon University School of Medicine
Division name Gastroenterology & Hepatology
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 03-3293-1711
Email ckusano2007@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chika kusano
Organization Nihon University School of Medicine
Division name Gastroenterology & Hepatology
Zip code
Address 1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL 03-3293-1711
Homepage URL
Email ckusano2007@yahoo.co.jp

Sponsor
Institute yuri-honjo, nikaho city
Institute
Department

Funding Source
Organization yuri-honjo, nikaho city
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
2015 Year 03 Month 27 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 Preinitiation
Date of protocol fixation
2015 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 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 p random sampling study.

Management information
Registered date
2015 Year 03 Month 26 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019654

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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