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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name