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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028641
Receipt No. 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 2019/08/13

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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 20

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
Email 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
Email kaname-1@umin.ac.jp

Sponsor
Institute Tohoku university
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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