UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021733 |
|---|---|
| Receipt number | R000025072 |
| Scientific Title | Study of the accuracy of urine and serum antibody test of H.pylori for junior high school students. |
| Date of disclosure of the study information | 2016/04/02 |
| Last modified on | 2016/04/01 15:28:32 |
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Basic information
Public title
Study of the accuracy of urine and serum antibody test of H.pylori for junior high school students.
Acronym
Study of the accuracy of urine and serum antibody test of H.pylori for junior high school students.
Scientific Title
Study of the accuracy of urine and serum antibody test of H.pylori for junior high school students.
Scientific Title:Acronym
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
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 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
| 1st name | |
| Middle name | |
| Last name | Kusano Chika |
Organization
Yuri Kumiai general hospital
Division name
Gastroenterology
Zip code
Address
Yago 38, Kawaguchi aza, Yurihonjo city, Akita, japan
TEL
0184-27-1200
ckusano2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kusano Chika |
Organization
Yuri Kumiai general hospital
Division name
Gastroenterology
Zip code
Address
Yago 38, Kawaguchi aza, Yurihonjo city, Akita, japan
TEL
0184-27-1200
Homepage URL
ckusano2007@yahoo.co.jp
Sponsor or person
Institute
Yuri Kumiai general hospital
Institute
Department
Personal name
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)
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
| 2016 | Year | 04 | Month | 02 | 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
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025072
