UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014172 |
|---|---|
| Receipt number | 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 15:06:32 |
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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
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
okuda@naxnet.or.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016496
