UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022824 |
|---|---|
| Receipt number | R000026308 |
| Scientific Title | Comprehensive assessment of the association between exosome-derived miRNA expression in gastric juice and functional dyspepsia |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2020/01/31 15:32:07 |
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Basic information
Public title
Comprehensive assessment of the association between exosome-derived miRNA expression in gastric juice and functional dyspepsia
Acronym
Exosome-derived miRNA expressions in gastric juice of functional dyspepsia patients
Scientific Title
Comprehensive assessment of the association between exosome-derived miRNA expression in gastric juice and functional dyspepsia
Scientific Title:Acronym
Exosome-derived miRNA expressions in gastric juice of functional dyspepsia patients
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify the specific exosome-derived miRNA expression in gastric juice of fuctional dyspepsia patients.
Basic objectives2
Others
Basic objectives -Others
The analysis of pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The expression of exosome-derived miRNA in gastric juice
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
The patients underwent esophagogastroduodenoscopy and analysis of anti-Helicobacter pylori (H.pylori) IgG antibody. The patients who wrote questionaire and informed consent.
Key exclusion criteria
The patients who have severe diseases of heart, lung, liver, kidney, thyroid, mental, and cancer.
The patients who have organic diseases of upper gastrointestinal tract; gastric and duodenal ulcer, gastric cancer and adenoma
The patients who had history of operarion in abdomen
The patients who take anti-acid drugs
The patients who take NSAIDs
The patients who take anti-coagulants
The patients who did not have assement of H.pylori eradication
The patients who had unknown history of H.pylori eradication
H.pylori IgG showed false-negative
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
0666453811
m2079981@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | TANAKA |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka City, Osaka
TEL
0666453811
Homepage URL
m2079981@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Hospital Certified Review Board
Address
Abeno Medix 6F, 1-2-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6646-6125
ethics@med.osaka-cu.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
| 2016 | Year | 06 | Month | 21 | 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
22
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of this study was published.
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026308
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
