UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032689 |
|---|---|
| Receipt number | R000037279 |
| Scientific Title | Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/05/23 17:58:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan
Acronym
Evaluation of WOS in gastric epithelial tumor detected after H. pylori eradication by administration of bonoprazain
Scientific Title
Evaluation of white opaque substance in gastric epithelial tumor detected after H. pylori eradication by administration of vonoprazan
Scientific Title:Acronym
Evaluation of WOS in gastric epithelial tumor detected after H. pylori eradication by administration of bonoprazain
Region
| Japan |
Condition
Condition
gastric epithelial tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to investigate whether antacid agents increase the density of the WOS in gastric epithelial tumors, especially detected after H. pylori eradication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in tumor WOS expression (positive proportion) before and after Vonoprazan administration.
Key secondary outcomes
Relationship between WOS expression and fasting gastric juice pH.
Relationship between WOS expression and tumor histopathology (adenoma VS differentiation dominant VS undifferentiated dominant)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan 20 mg administration for 21 days
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
Planned to undergo endoscopic resection (ESD or EMR) for early gastric cancer and gastric adenomas discovered after successful eradication.
2. For early gastric cancer, absolute adaptive lesion and adaptive enlarged lesion are treated as the target lesion according to the gastric cancer treatment guideline.
3. ECOG-performance Status is 0 or 1.
4. For participation in the study, informed consent was obtained.
Key exclusion criteria
Patients within 6 months from the day of eradication
2. Patients with antacid drugs before the first observation (within 7 days)
3. Patients with lesions with ulcers and bleeding which are difficult to observe the surface of the lesion
4. Patients with severe underlying disease
5. Patients with a history of gastrectomy
6. Patients who have complicated mental illness or psychiatric symptoms and seem to be difficult to participate in the study.
7. Other patients who are deemed inappropriate for the trial responsible physician or the test sharing doctor to conduct this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Ueo |
Organization
Oita Red Cross Hospital
Division name
Gastroenterology
Zip code
Address
Chiyo-machi, Oita 870-0033
TEL
0975326181
ueo14@athena.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Ueo |
Organization
Oita Red Cross Hospital
Division name
Gastroenterology
Zip code
Address
Chiyo-machi, Oita 870-0033
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
Other
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
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037279
