UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030632 |
|---|---|
| Receipt number | 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 | 2020/01/04 10:42:26 |
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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
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
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University Faculty of Medicine
Institute
Department
Personal name
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
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
https://www.hospital.med.saga-u.ac.jp/chiken/data/rinsyou_gijigaiyou/H29.04rinsyou_gijigaiyou.pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.hospital.med.saga-u.ac.jp/chiken/data/rinsyou_gijigaiyou/H29.04rinsyou_gijigaiyou.pdf
Number of participants that the trial has enrolled
Results
Of the 57 middle school students with H. pylori, the Nested PCR-QP test results of 53 (90.3%) could be analyzed; 28 students were found to have CAM resistance mutations. The results indicating genetic mutation in 28 and no mutation in 23 students were consistent with those of PCR-direct sequencing.
Results date posted
| 2020 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were middle school students in Saga Prefecture who underwent H. pylori testing between August and December 2017 under our program to eliminate gastric cancer. Consent to participate in the study was obtained from 71 middle school students.
Participant flow
Of the 57 middle school students with H. pylori, the Nested PCR-QP test results of 53 (90.3%) could be analyzed; 28 students were found to have CAM resistance mutations. The results indicating genetic mutation in 28 and no mutation in 23 students were consistent with those of PCR-direct sequencing.
Adverse events
None
Outcome measures
Nested PCR-QP detection sensitivity and correlation with eradication therapy
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034977
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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