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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030632
Receipt No. R000034977
Scientific Title Diagnostic accuracy of fecal Helicobacter pylori antigen rapid detection reagent and gene detection reagent
Date of disclosure of the study information 2017/12/29
Last modified on 2019/07/12

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Basic information
Public title Diagnostic accuracy of fecal Helicobacter pylori antigen rapid detection reagent and gene detection reagent
Acronym Diagnostic accuracy of fecal Helicobacter pylori antigen rapid detection reagent and gene detection reagent
Scientific Title Diagnostic accuracy of fecal Helicobacter pylori antigen rapid detection reagent and gene detection reagent
Scientific Title:Acronym Diagnostic accuracy of fecal Helicobacter pylori antigen rapid detection reagent and gene detection reagent
Region
Japan

Condition
Condition Helicobacter pylori
Classification by specialty
Gastroenterology Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Our test reagent is evaluated for correlation with fecal H. pylori antigen test kit (Wakamoto Pharmaceutical Co., Ltd.) and real time PCR method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes 1, Our fecal H. pylori antigen detection reagent is evaluated for correlation with fecal H. pylori antigen test kit (Wakamoto Pharmaceutical Co., Ltd.)
2, Our fecal H. pylori antigen test kit is evaluated for correlation with real time PCR method.
3, Our fecal H. pylori gene detection reagentis evaluated for correlation with fecal H. pylori antigen test kit (Wakamoto Pharmaceutical Co., Ltd.)
4,Our fecal H. pylori gene detection reagentis evaluated for correlation with real time PCR method.
5,Our fecal H. pylori gene detection reagentis evaluated for correlation with PCR Direct Sequence Method.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
14 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria In Saga Prefecture's commissioned project "Stomach Cancer Prevention Project for the Future", student who receive H. pylori antigen test in feces is eligible.
Key exclusion criteria 1, Person who do not obtain consent from principal or substitute (guardian).
2,Person who has judged that the research director has a problem in participation.
3,Person who have already taken H. pylori eradication treatment.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Toshihiko
Middle name
Last name Kakiuchi
Organization Saga University Faculty of Medicine
Division name Pediatrics
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga-City, 849-8501 Japan
TEL 0952-34-2314
Email kakiucht@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Kimura
Organization Saga University Hospital
Division name Clinical Research Center
Zip code 849-8501
Address 5-1-1 Nabeshima, Saga-City, 849-8501 Japan
TEL 0952-34-3400
Homepage URL
Email kenkyu-shinsei@ml.cc.saga-u.ac.jp

Sponsor
Institute Saga University Faculty of Medicine
Institute
Department

Funding Source
Organization MIZUHO MEDY Co Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization CLINICAL RESEARCH CENTER, SAGA UNIVERSITY HOSPITAL
Address 5-1-1 Nabeshima, saga-City, 849-8501 Japan
Tel 0952-34-3400
Email kenkyu-shinsei@ml.cc.saga-u.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
2017 Year 12 Month 29 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
2017 Year 07 Month 03 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information We confirmed its clinical usefulness by conducting performance evaluation using clinical specimens for newly developed "H. pylori antigen rapid detection reagent in faeces" and "H. pylori gene detection reagent in feces" .

Management information
Registered date
2017 Year 12 Month 29 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034977

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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