UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045892 |
|---|---|
| Receipt number | R000052393 |
| Scientific Title | Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste. |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/10/28 09:44:24 |
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Basic information
Public title
Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Acronym
Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Scientific Title
Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Scientific Title:Acronym
Clinical study on the efficacy of H. pylori molecular diagnostic kit.
Testing with stool and gastric wash waste.
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the efficacy of the each H. pylori molecular diagnostic kits using stool and gastric wash waste compared with conventional H. pylori diagnostic methods as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For H. pylori molecular diagnostic kit using gastric wash waste, evaluation of the correlation with H. pylori conventional diagnostic method (urea breath test, stool antigen test, culture) and evaluation of the concordance with clarithromycin antibiotic susceptibility test.
For H. pylori molecular diagnostic kit using stool, evaluation of the sensitivity compared with stool antigen test, and evaluation of the concordance with clarithromycin antibiotic susceptibility test.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following conditions
(1) Patients suspected of H. pylori infection and recommended to undergo endoscopy
(2) Patients who consented to conduct a urea breath test (UBT) and submit stool (stool H. pylori antigen test) before endoscopy
(3) 15 years old and over
Key exclusion criteria
Patients who meet any of the following conditions
(1) Patients who did not obtain sufficient samples for the study
(2) Patients who have already received H. pylori eradication treatment
(3) Patients with serious disabilities
(4) Pregnant or potentially pregnant patients
(5) Other patients who the attending physician has determined to be unable to participate in the study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Mototsugu |
| Middle name | |
| Last name | Kato |
Organization
National Hospital Organization Hakodate National Hospital
Division name
Department of Gastroenterology
Zip code
041-8512
Address
18-16 Kawahara-cho, Hakodate City, Hokkaido, Japan
TEL
0138-51-6281
kato.mototsugu.ym@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Ebisu |
Organization
MIZUHO MEDY Co., Ltd.
Division name
R&D Planning Dept.
Zip code
841-0048
Address
5-4 Fujinoki-Machi, Tosu City, Saga, Japan
TEL
0942-85-0301
Homepage URL
ebisu@mizuho-m.co.jp
Sponsor or person
Institute
MIZUHO MEDY Co., Ltd.
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
National Hospital Organization Hakodate National Hospital, Ethics Review Boad
Address
18-16 Kawahara-cho, Hakodate City, Hokkaido, Japan
Tel
0138-51-6281
102-kanrikat@mail.hosp.go.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
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
143
Results
For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%.
For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.
Results date posted
| 2021 | Year | 10 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
143 out of 151 patients enrolled participated (Male 54/Female 89, Median age: 64 with range of 19-90)
Participant flow
Obtained informed consent from patients suspected H. pylori infection. 143 out of 151 patients enrolled participated. Participants underwent an conventional H. pylori infection diagnostic method (urea breath test, stool antigen test, culture, antibiotic susceptibility test) and EGD (Esophagogastroduodenoscopy) . Stool and gastric wash waste were collected from the participants. Using the collected samples, evaluation of H. pylori molecular diagnostic kits, real-time PCR method, and sequencing were carried out.
Adverse events
No adverse events were observed.
Outcome measures
For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%.
For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtained informed consent from patients suspected H. pylori infection. 143 out of 151 patients enrolled participated. Participants underwent an conventional H. pylori infection diagnostic method (urea breath test, stool antigen test, culture, antibiotic susceptibility test) and EGD (Esophagogastroduodenoscopy) . Stool and gastric wash waste were collected from the participants. Using the collected samples, evaluation of H. pylori molecular diagnostic kits, real-time PCR method, and sequencing were carried out.
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052393
