UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039863 |
|---|---|
| Receipt number | R000045456 |
| Scientific Title | Analysis of lymphocyte composition in the gastric mucosa with a gastric cancer developed after eradication of Helicobacter pylori |
| Date of disclosure of the study information | 2020/03/18 |
| Last modified on | 2023/03/06 11:42:06 |
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Basic information
Public title
Analysis of lymphocyte composition in the gastric mucosa with a gastric cancer developed after eradication of Helicobacter pylori
Acronym
Analysis of lymphocyte composition in the gastric mucosa
Scientific Title
Analysis of lymphocyte composition in the gastric mucosa with a gastric cancer developed after eradication of Helicobacter pylori
Scientific Title:Acronym
Analysis of lymphocyte composition in the gastric mucosa
Region
| Japan |
Condition
Condition
Patients after Helicobacter pylori eradication treatment
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the lymphocyte fractions of the gastric mucosa in gastric cancer patients who had eradicated Helicobacter pylori
Basic objectives2
Others
Basic objectives -Others
To investigate the differences of lymphocyte fractions between the gastric mucosa with or without gastric cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences of lymphocyte fractions between the gastric mucosa with and without a gastric cancer
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who eradicated Helicobacter pylori
Key exclusion criteria
none
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
iwamuromasaya@yahoo.co.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 | 03 | Month | 18 | Day |
Related information
URL releasing protocol
doi: 10.1097/MD.0000000000030241.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1097/MD.0000000000030241.
Number of participants that the trial has enrolled
20
Results
The lymphocyte subsets of the antrum and lesser curvature of the body were similar. In contrast, compared to those in the greater curvature of the gastric body, CD4+/CD3+ lymphocyte subsets were elevated in the lesser curvature of the body, whereas CD8+/CD3+, CD7+/CD3+, CCR4+/CD3+, CD45RA+/CD3+CD4+, and CD45RA+/CD3+CD4- were lower. Linear regression analysis showed a negative correlation between the time after H. pylori eradication and CD4+/CD3+.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients after Helicobacter pylori eradication
Participant flow
To investigate site-specific differences in stomach-resident T lymphocytes after H. pylori eradication, we performed flow cytometry analysis on samples taken from the gastric antrum, greater curvature of the gastric body, and lesser curvature of the gastric body of 20 patients.
Adverse events
None
Outcome measures
flow cytometry analysis on samples taken from the gastric antrum, greater curvature of the gastric body, and lesser curvature of the gastric body
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
enrolling patients
Management information
Registered date
| 2020 | Year | 03 | Month | 18 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045456
