UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051322 |
|---|---|
| Receipt number | R000058541 |
| Scientific Title | Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/12 01:00:31 |
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Basic information
Public title
Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Acronym
Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Scientific Title
Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Scientific Title:Acronym
Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Region
| Japan |
Condition
Condition
intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Genetic mutation analysis of intestinal-type gastric dysplasia in Helicobacter pylori-naive patients
Basic objectives2
Others
Basic objectives -Others
clinicopathologic features
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genetic mutation analysis by the whole exome sequencing
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with gastric neoplasm of differentiated type that occurred in the gastric antrum and was histologically diagnosed with intestinal-phenotype
2. Patients that is diagnosed as being naive for Helicobacter pylori-infection
3. fixed with 10% formalin neutral buffer solution
Key exclusion criteria
1. Patient who refused to be registered
2. Diagnosed as defective quality of extracted DNA
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Shimane University Hospital
Division name
Endoscopy
Zip code
6938501
Address
89-1 Enya Izumo
TEL
0853202190
kotaro@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Shibagaki |
Organization
Shimane University Hospital
Division name
Endoscopy
Zip code
6938501
Address
same as above
TEL
0853202190
Homepage URL
kotaro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Kotaro Shibagaki
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same above
Address
same as above
Tel
0853202190
kotaro@med.shimane-u.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
| 2023 | Year | 07 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2023 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058541
| Research Plan | |
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| 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 |
