UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054538 |
|---|---|
| Receipt number | R000062273 |
| Scientific Title | Surveillance of non-Helicobacter pylori Helicobacter species infection in the human stomach |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/12/23 14:46:22 |
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Basic information
Public title
Surveillance of non-Helicobacter pylori Helicobacter species infection in the human stomach
Acronym
Surveillance of NHPH in the human stomach
Scientific Title
Surveillance of non-Helicobacter pylori Helicobacter species infection in the human stomach
Scientific Title:Acronym
Surveillance of NHPH in the human stomach
Region
| Japan |
Condition
Condition
Healthy subjects, gastric and duodenal ulcers, gastric MALT lymphoma, gastric cancer, gastritis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although a few cases have been reported in which gastroduodenal diseases are associated with (NHPH), knowledge on this topic is scarce. Therefore, we will conduct a multi-center survey of the actual status of NHPH in healthy individuals (medical checkups) and gastroduodenal diseases such as gastritis, gastroduodenal ulcers, gastric MALT lymphoma, and gastric cancer.
Basic objectives2
Others
Basic objectives -Others
Usefulness of H. suis serological diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify the infection rate of NHPH in healthy individuals (medical checkups), those with gastric and duodenal ulcers, gastric MALT lymphoma, gastric cancer, and gastritis.
Key secondary outcomes
Evaluation of NHPH infection cases
1. Identification of bacterial species (H. suis or other H. suis)
2. Evaluation of patient background (age, sex, history of keeping pets, history of taking porcine hormones, etc.)
3. Evaluation of endoscopic findings
4. Evaluation of diagnostic methods (ELISA)
5. Evaluation of gastric microbiota
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who visit the Kyorin University Hospital or any of the facilities participating in this study and undergo upper gastrointestinal endoscopy as part of health insurance coverage, and those who undergo upper gastrointestinal endoscopy for the purpose of a health check.
(2) Those who have given verbal and written consent to participate in this study.
(3) Those aged 20 years or older.
Key exclusion criteria
(1) Persons who are unable to give consent to participate in this study.
(2) Persons who lack the capacity to give consent to participate in this study.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | KENGO |
| Middle name | |
| Last name | TOKUNAGA |
Organization
Kyorin University School of Medicine
Division name
Department of Preventive Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
kentoku@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | KENGO |
| Middle name | |
| Last name | TOKUNAGA |
Organization
Kyorin University School of Medicine
Division name
Department of Preventive Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
kentoku@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
KENGO TOKUNAGA
Funding Source
Organization
Japan Agency for Medical Research and Development, Health and Labor Sciences Research Grant,MEXT,JSPS, Japanese Society of Helicobacter Research,
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Department of Gastroenterology, Faculty of Medicine, Oita University, Junpukai Health Maintenance Center-Kurashiki, Department of Internal Medicine, Kenwakai Hospital, Hakodate Hospital, Public Interest Foundation Hokkaido Cancer Society, Department of Internal Medicine, Aomori General Health Examination Center, Department of Bacteriology II, National Institute of Infectious Diseases, Department of Biomedical Laboratory Sciences, Shinshu University School of Medicine, Department of Bacteriology, Nagoya University Graduate School of Medicine, Department of Gastroenterological Endoscopy, Tokyo Medical University, Division of Genome-Wide Infectious Microbiology, Research Center for GLOBAL and LOCAL Infectious Disease, Oita University, Department of Internal Medicine, Kawasaki Medical School, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Department of Gastroenterology, Juntendo University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Research Ethics Committee
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
21001
Org. issuing International ID_1
Japanese Society of Helicobacter Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学医学部付属病院(東京都)、健和会病院(長野県)、札幌がん検診センター(北海道)、淳風会健康管理センター倉敷(岡山県)、東海大学医学部付属病院(神奈川県)、東京医科大学病院(東京都)、大分大学医学部附属病院(大分県)、函館病院(北海道)、川崎医科大学病院(岡山県)、順天堂大学病院(東京都)、慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 31 | 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
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study to clarify the NHPH infection rate in healthy individuals and patients with gastroduodenal diseases by investigating the actual infection status of NHPH in Japan, and to evaluate the bacterial species associated with NHPH infection, patient background, endoscopic findings, and the usefulness of serological diagnostic methods.
Management information
Registered date
| 2024 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062273
