UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028641 |
|---|---|
| Receipt number | R000032781 |
| Scientific Title | Role of gastric mucosal barrier dysfunction during gastric carcinogenesis after H.pylori eradication |
| Date of disclosure of the study information | 2017/09/22 |
| Last modified on | 2024/02/15 09:27:20 |
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Basic information
Public title
Role of gastric mucosal barrier dysfunction during gastric carcinogenesis after H.pylori eradication
Acronym
Mucosal barrier dysfunction during gastric carcinogenesis after H.pylori eradication
Scientific Title
Role of gastric mucosal barrier dysfunction during gastric carcinogenesis after H.pylori eradication
Scientific Title:Acronym
Mucosal barrier dysfunction during gastric carcinogenesis after H.pylori eradication
Region
| Japan |
Condition
Condition
gastric cancer after successful eradication
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify mucosal barrier damage due to factors of gastric juice after eradication
Basic objectives2
Others
Basic objectives -Others
To clarify difference in mucosal barrier dysfunction caused by acetaldehyde or paptideglycan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in mucosal barrier dysfunction caused by acetaldehyde or peptideglycan
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
endoscopic biopsy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with follow-up endoscopic examination after ESD for post-eradication gastric cancer
Key exclusion criteria
1. contraindication for endoscoic biopsy
2. patients who take NSAIDs, steroid, or immunosuppressive medication
3. patients treated by surgecy for upper GI tract
4. patients who take antibiotics in 12 months
5. pregnancy
6. severe general condition or phycological dysorder
7. inappropriate for enrolling this trial
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku university
Division name
Gastroenterology
Zip code
981-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai, Miyagi, Japan
TEL
022-717-7171
kaname-1@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kaname |
| Middle name | |
| Last name | Uno |
Organization
Tohoku university
Division name
Gastroenterology
Zip code
981-8574
Address
1-1 Seiryo-cho, aobaku, Sendai, Miyagi, Japan
TEL
022-717-7171
Homepage URL
kaname-1@umin.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
Tohoku univerisity
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
Tohoku University Hospital IRB
Address
1-1 Seiryo-cho Aoba-ku Sendai Miyagi
Tel
022-728-4105
office@nrs.hosp.tohoku.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
| 2017 | Year | 09 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/37943385/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/37943385/
Number of participants that the trial has enrolled
40
Results
Methods: To evaluate barrier function of background mucosa against the stimulations, we applied biopsy samples from 76 patients on mini-Ussing chamber system and immunohistochemical study.
Results: In the UCs, Pg. lipopolysaccharide reduced the impedance of metaplastic and inflamed mucosa with increases in mRNA expression of toll-like receptor 2, tumor necrosis factor, and apoptotic markers.
Results date posted
| 2024 | Year | 02 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty patients with GC detected at least 2 years after successful H. pylori eradication therapy (post-eradication GC), who visited our department between June 2019 and November 2020, were enrolled in this study.
Participant flow
Under endoscopic inspection, three biopsy samples were obtained from background mucosa suffering from GC, and they were separately applied to histological studies, a mini-Ussing chamber system (mUCs), and molecular biological studies.
Adverse events
none
Outcome measures
biopsy samples to mUCs to evaluate changes in the mucosal barrier function by external stimulations
The degree of inflammation, activity, atrophy, and metaplasia of endoscopic biopsy specimens was evaluated based on the uSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032781
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