UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the accuracy of urine antibody test and stool antigen test of H.pylori for junior high school students.
Title of the study (Brief title)	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	Chika Kusano
Organization	Nihon University School of Medicine
Division name	Gastroenterology & Hepatology
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	03-3293-1711
Email	ckusano2007@yahoo.co.jp

Public contact
Name of contact person	Chika kusano
Organization	Nihon University School of Medicine
Division name	Gastroenterology & Hepatology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019654