UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the accuracy of urine and serum antibody test of H.pylori for junior high school students.
Title of the study (Brief title)	Study of the accuracy of urine and serum antibody 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 and serum.
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study of the accuracy of urine and serum antibody 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 and serum antibody test for H. pylori infection.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	12 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	who had urinary and serum 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	800

Research contact person
Name of lead principal investigator	Kusano Chika
Organization	Yuri Kumiai general hospital
Division name	Gastroenterology
Address	Yago 38, Kawaguchi aza, Yurihonjo city, Akita, japan
TEL	0184-27-1200
Email	ckusano2007@yahoo.co.jp

Public contact
Name of contact person	Kusano Chika
Organization	Yuri Kumiai general hospital
Division name	Gastroenterology
Address	Yago 38, Kawaguchi aza, Yurihonjo city, Akita, japan
TEL	0184-27-1200
Homepage URL
Email	ckusano2007@yahoo.co.jp

Sponsor
Institute	Yuri Kumiai general hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	No
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	2016 Year 04 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 01 Month 15 Day
Anticipated trial start date	2016 Year 04 Month 13 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	No

Management information
Registered date	2016 Year 04 Month 01 Day
Last modified on	2016 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025072