UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061843 |
|---|---|
| Receipt number | R000070768 |
| Scientific Title | A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 12:07:20 |
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Basic information
Public title
A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests
Acronym
A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests
Scientific Title
A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests
Scientific Title:Acronym
A Retrospective Study to Evaluate the Accuracy of Helicobacter pylori Diagnostic Tests
Region
| Japan |
Condition
Condition
H .pylori infection
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several diagnostic methods are available for Helicobacter pylori infection, including the urea breath test, stool antigen test, serum antibody test, culture, rapid urease test, and histological examination. In November 2022, gastric fluid PCR testing for H. pylori and clarithromycin resistance genes became covered by the Japanese national health insurance system, enabling diagnosis without gastric biopsy during endoscopy. Although gastric fluid PCR has shown high concordance with established diagnostic methods, its accuracy in patients after H. pylori eradication therapy remains unclear. This retrospective study aims to evaluate the accuracy of gastric fluid PCR testing for identifying current infection, uninfected status, and post-eradication status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of Gastric Fluid PCR Testing for Helicobacter pylori Infection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent testing for Helicobacter pylori infection at Keio University Hospital between September 2022 and August 2024.
Key exclusion criteria
Patients who declined the use of their clinical data for research purposes.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
mori-d@keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mori-d@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-ft_pt@adst.keio.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
| 2026 | Year | 06 | Month | 09 | 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
1550
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2026 | Year | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070768
