UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055050 |
|---|---|
| Receipt number | R000062889 |
| Scientific Title | A Retrospective Study to Evaluate the Effectiveness of Personalized Medicine in the Tertiary Eradication of Helicobacter pylori |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/23 12:41:04 |
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Basic information
Public title
A Retrospective Study to Evaluate the Effectiveness of Personalized Medicine in the Tertiary Eradication of Helicobacter pylori
Acronym
A Retrospective Study to Evaluate the Effectiveness of Personalized Medicine in the Tertiary Eradication of Helicobacter pylori
Scientific Title
A Retrospective Study to Evaluate the Effectiveness of Personalized Medicine in the Tertiary Eradication of Helicobacter pylori
Scientific Title:Acronym
A Retrospective Study to Evaluate the Effectiveness of Personalized Medicine in the Tertiary Eradication of Helicobacter pylori
Region
| Japan |
Condition
Condition
Patients with H. pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the validity of personalized medicine in tertiary eradication of H. pylori
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eradication rate of H. pylori by individualized treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients treated for tertiary eradication at Keio University Hospital and Kitasato Institute Hospital of Kitasato University from November 2019 to March 2024.
2. patients who have undergone drug susceptibility testing prior to tertiary eradication.
3. patients who are 18 years of age or older.
Key exclusion criteria
1. patients allergic to sitafloxacin or rifabutin
2. patients after fourth-line eradication
3. patients who refused to use clinical data
4. patients for whom the eradication treatment decision could not be made or for whom the results are unknown
5. patients for whom information on the eradication treatment regimen or drug dosage is unknown
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Department of Internal Medicine, 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
koyamaru2002@yahoo.co.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
03
Homepage URL
koyamaru2002@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
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
| 2024 | Year | 07 | Month | 24 | 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
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study of patients treated for tertiary eradication of H. pylori at Keio University Hospital and Kitasato University Kitasato Research Institute Hospital between November 2019 and March 2024. This is an individual case study to obtain existing patient information, and information will be obtained by a survey form. The study will be conducted according to the following schedule.
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062889
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
