UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044707 |
|---|---|
| Receipt number | R000051063 |
| Scientific Title | Identification of endoscopic findings predicting the appearance of map-like redness after Helicobacter pylori eradication therapy: Multicenter prospective study |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/04/02 14:20:18 |
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Basic information
Public title
Identification of endoscopic findings predicting the appearance of map-like redness after Helicobacter pylori eradication therapy: Multicenter prospective study
Acronym
Map-like reddish endoscopic appearance prediction marker
Scientific Title
Identification of endoscopic findings predicting the appearance of map-like redness after Helicobacter pylori eradication therapy: Multicenter prospective study
Scientific Title:Acronym
Map-like reddish endoscopic appearance prediction marker
Region
| Japan |
Condition
Condition
H. pylori positive gastritis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify endoscopic findings that predict the appearance of map-like redness before H. pylori eradication therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify endoscopic findings that predict the appearance of map-like redness before H. pylori eradication therapy
Key secondary outcomes
(1) Occurrence rate of map-like redness after H. pylori eradication treatment
(2) Appearance site of map-like redness after eradication therapy
(3) Prediction of the appearance of map-like redness Identification of an excellent IEE method for detecting endoscopic findings
(4) Differences of endoscopy models to evaluate map-like redness
(5) Histopathological examination of appearance prediction part before eradication treatment
(6) Correlation between the appearance of map-like redness and pepsinogen levels
(7) Relationship between map-like redness and Kyoto gastritis classification
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. H. pylori positive patients aged 20 years
2. Performance status; 0 and 1 point
3. Patients receiving informed consent
Key exclusion criteria
1. patients with serious complications (heart failure, liver failure, respiratory failure)
2. Pregnant or lactating
3. Patients who are taking two or more types of antithrombotic drugs
Target sample size
129
Research contact person
Name of lead principal investigator
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterological Endoscopy
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
sugimo@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Mitsushige |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University Hospital
Division name
Department of Gastroenterological Endoscopy
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
sugimo@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Endoscopy,
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Endoscopy,
Tokyo Medical University Hospital
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
Institutional Review Board, Tokyo mEdical University Hospotal
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
Sys_IRB@tokyo-med.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
| 2021 | Year | 07 | Month | 01 | 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 | 06 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Multicenter research
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051063
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
