UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019248 |
|---|---|
| Receipt number | R000022251 |
| Scientific Title | Evaluation of plasma Chromogranin A before and after treatment with various acid inhibitors |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2023/03/31 17:15:58 |
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Basic information
Public title
Evaluation of plasma Chromogranin A before and after treatment with various acid inhibitors
Acronym
Acid inhibitors and Chromogranin A
Scientific Title
Evaluation of plasma Chromogranin A before and after treatment with various acid inhibitors
Scientific Title:Acronym
Acid inhibitors and Chromogranin A
Region
| Japan |
Condition
Condition
acid-related gastrointestinal diseases
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of acid inhibitors on ECL cell hyperplasia.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between type of acid inhibitors and ECL cell hyperplasia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma Chromogranin A
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with acid-related gastrointestinal diseases, who were scheduled to treat with acid inhibitors for more than one month.
2) Patients with acid-related gastrointestinal diseases, who have been treated with acid inhibitors for more than 2 months.
3) Patients with written informed consent.
Key exclusion criteria
Patients who are not eligible for participation judged by a doctor.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Second department of Internal Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
ishimura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Second department of Internal Medicine
Zip code
Address
89-1, Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2015 | Year | 10 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A study before and after administration acid blocker (cohort study) and study during administration with acid blocker (cross-sectional study).
Enrollment of the patients: all patients who met the inclusion criteria after October 2015.
Management information
Registered date
| 2015 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022251
| 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 |
