UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040962 |
|---|---|
| Receipt number | R000046693 |
| Scientific Title | Prospective study on association between endoscopic hematin findings and gastric acidity |
| Date of disclosure of the study information | 2020/07/06 |
| Last modified on | 2020/07/01 08:59:25 |
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Basic information
Public title
Prospective study on association between endoscopic hematin findings and gastric acidity
Acronym
Prospective study on association between endoscopic hematin findings and gastric acidity
Scientific Title
Prospective study on association between endoscopic hematin findings and gastric acidity
Scientific Title:Acronym
Prospective study on association between endoscopic hematin findings and gastric acidity
Region
| Japan |
Condition
Condition
Screening upper endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether endoscopically visualized hematin can be a finding indicating a strong acid environment in the stomach
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the presence of hematin and fasting gastric juice pH
Key secondary outcomes
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of endoscopic hematin for predicting strong acidity
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 who will underwent upper gastrointestinal screening endoscopy
2. ECOG-performance Status is 0 or 1.
3. The age at registration is 20 years or older.
4. Written informed consent from the patient to participate in the study.
Key exclusion criteria
1. Patients who started or stopped taking antacid within the last 7 days including the date of endoscopic examination.
2. Patients with serious underlying diseases (cirrhosis/end stage renal failure)
3. Patients with a history of gastrectomy
4. 4. Patients with mental illness or symptoms who may have difficulty participating in the study.
5. Other patients who are deemed inappropriate for the trial responsible physician or the test sharing doctor to conduct this study
Target sample size
325
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ueo |
Organization
Oita Red Cross Hospital
Division name
Gastroenterology
Zip code
870-0033
Address
Chiyo-machi, Oita
TEL
0975326181
ueo14@athena.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ueo |
Organization
Oita Red Cross Hospital
Division name
Gastroenterology
Zip code
870-0033
Address
Chiyo-machi, Oita
TEL
0975326181
Homepage URL
ueo14@athena.ocn.ne.jp
Sponsor or person
Institute
Oita Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Oita Red Cross 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
Ethics Committee of Oita Red Cross Hospital
Address
Chiyo-machi, Oita
Tel
0975326181
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
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cross-sectional study to prospectively evaluate hematin and fasting gastric juice pH
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046693
| 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 |
