UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040999 |
|---|---|
| Receipt number | R000046814 |
| Scientific Title | Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study) |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2020/07/04 13:28:50 |
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Basic information
Public title
Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)
Acronym
Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)
Scientific Title
Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)
Scientific Title:Acronym
Prospective study on the relationship between endoscopic findings based on Kyoto classification of gastritis and strong acidic condition in the stomach (Pilot study)
Region
| Japan |
Condition
Condition
Esophagogastroduodenoscopy for screening purposes
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining endoscopic findings based on Kyoto classification of gastritis from the viewpoint of gastric acid environment, and clarifying endoscopic findings useful for evaluation of strong acidic condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictability for strong acidic condition of endoscopic findings based on Kyoto classification of gastritis
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. Planning to undergo esophagogastroduodenoscopy for screening purposes at our hospital.
2. ECOG-Performance Status is 0 or 1.
3. The age at the time of registration is 20 years or older.
4. Written informed consent to participate in the study is obtained.
Key exclusion criteria
1. Patients who started or stopped taking antacid within the last 7 days including the date of endoscopy.
2. Patients with serious underlying disease (cirrhosis/end stage renal failure).
3. Patients with a history of gastrectomy.
4. Patients with psychiatric disorders or symptoms who may have difficulty participating in the study.
5. In addition, patients who are considered unsuitable for conducting this study by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Katsuta |
Organization
Oita Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
870-0033
Address
3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan
TEL
097-532-6181
katsuta@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Katsuta |
Organization
Oita Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
870-0033
Address
3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan
TEL
097-532-6181
Homepage URL
katsuta@oita-u.ac.jp
Sponsor or person
Institute
Oita Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Oita Red Cross Hospital
Address
3-2-27, Chiyo-Machi, Oita-shi, Oita, Japan
Tel
097-532-6181
soumukikaku@oita-rc-hp.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
| 2020 | Year | 07 | Month | 06 | 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
| 2020 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe in the stomach using an esophagogastroduodenoscope and check the presence of 19 findings based on Kyoto classification of gastritis and pH of fasting gastric juice.
Management information
Registered date
| 2020 | Year | 07 | Month | 04 | Day |
Last modified on
| 2020 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046814
