UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018967 |
|---|---|
| Receipt number | R000021945 |
| Scientific Title | Alteration of the permiability in Gastric tissue after successful eradication of Helicobacter pylori by the stimulation of gastric acid and bile acid |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/01/19 13:49:54 |
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Basic information
Public title
Alteration of the permiability in Gastric tissue after successful eradication of Helicobacter pylori by the stimulation of gastric acid and bile acid
Acronym
The permiability in the post-eradication gastric mucosa
Scientific Title
Alteration of the permiability in Gastric tissue after successful eradication of Helicobacter pylori by the stimulation of gastric acid and bile acid
Scientific Title:Acronym
The permiability in the post-eradication gastric mucosa
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate post-eradication gastric carcinogenesis by investigating the alteration of gastric mucosal permiability by the stimulation of bile acid and gastric acid.
Basic objectives2
Others
Basic objectives -Others
To clarify the mechanism of controling the tissue permeability of gastric tissue after the successful eradication
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in the alteration of gastric permeability by the stimulation of gastric acid and bile acid between atrophic mucosa and non-atrophic mucosa
Key secondary outcomes
Difference in the alteration of tight junction-associated cascades by the stimulation of gastric acid and bile acid between atrophic mucosa and non-atrophic mucosa
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Congo-red chromoendoscopy
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
subjects with post-eradication gastric cancer which were pointed out after 24-months of the successful eradication
Key exclusion criteria
1)subjects taking steroid, immunosupressive agents, NSAIDs, PPI within 1-month
2)subjects treated by surgery for upper GI tract
3)contraindication of biopsy
4)contrainducation of gastrin injection
5)pregnancy
6)severe illness
7)phychiatry
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaname Uno |
Organization
Tohoku university
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-cho, aobaku, Sendai, Miyagi, Japan
TEL
+81-22-717-7171
kaname-1@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaname Uno |
Organization
Tohoku university
Division name
Division of Gastroenterology
Zip code
Address
1-1 Seiryo-cho, aobaku, Sendai, Miyagi, Japan
TEL
+81-22-717-7171
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
Japan
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Using a mini-Ussing chamber system for human biopsy specimens of the subjects suffering from early gastric cancer after eradication, we demonstrated that the exposure of acidic bile salts to ANA might cause serious barrier dysfunction. This mechanism might play an important role in the development of inflammation-associated carcinogenesis even after eradication.
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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 24 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 26 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2018 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021945
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