UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012036 |
|---|---|
| Receipt number | R000014054 |
| Scientific Title | Clinical investigation of Helicobacter pylori infection and eradication therapy. |
| Date of disclosure of the study information | 2013/10/15 |
| Last modified on | 2013/10/15 11:08:08 |
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Basic information
Public title
Clinical investigation of Helicobacter pylori infection and eradication therapy.
Acronym
Clinical investigation of Helicobacter pylori infection and eradication therapy.
Scientific Title
Clinical investigation of Helicobacter pylori infection and eradication therapy.
Scientific Title:Acronym
Clinical investigation of Helicobacter pylori infection and eradication therapy.
Region
| Japan |
Condition
Condition
Patients who undergo EGD.
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the current H. pylori status of patients who undergo Upper GI endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the past history of H. pylori eradication and the severity of endoscopic gastric atrophy.
Key secondary outcomes
To investigate the evaluation methods of H. pylori infection and the reason.
To investigate the correlation between frequency of evaluation of H. pylori infection and medication about anticoagulants.
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
Patients undergoing upper GI endoscopy at the Chofu-Touzan hospital
Key exclusion criteria
patients without agreement
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Kono |
Organization
Tokyo medical univarsity
Division name
Graduate student
Zip code
Address
Shinjuku-ku nishi-shinjuku6-7-1, Tokyo, Japan
TEL
09041598591
shin_kono0527@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Kono |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hepatology
Zip code
Address
Shinnjuku-ku nishi-shinnjuku6-7-1, Tokyo, Japan
TEL
09041598591
Homepage URL
shin_kono0527@yahoo.co.jp
Sponsor or person
Institute
Tokyo medical
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 15 | 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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is that patients are prospectively registered and cross-sectionally evaluated.
Management information
Registered date
| 2013 | Year | 10 | Month | 15 | Day |
Last modified on
| 2013 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014054
