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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042043
Receipt No. R000047981
Scientific Title Association between metabolic syndrome and esophageal-gastric junction cancer
Date of disclosure of the study information 2021/03/17
Last modified on 2021/03/17

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Basic information
Public title Role of metabolic syndrome in carcinogenesis of esophageal-gastric junction
Acronym Role of metabolic syndrome in carcinogenesis of esophageal-gastric junction
Scientific Title Association between metabolic syndrome and esophageal-gastric junction cancer
Scientific Title:Acronym Association between metabolic syndrome and esophageal-gastric junction cancer
Region
Japan

Condition
Condition esophago-gastric junction cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify a role of metabolic syndrome and peridontobacillus in inflammatory carcinogenesis of esophago-gastric junction
Basic objectives2 Others
Basic objectives -Others To clarify a role of metabolic syndrome andperiodontobacillus in inflammatory gastric carcinogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference between mucosal barrier dysfunction of esophago-gastric junction by the stimulation of acidic bile acid salts and periodontobacillus between esophago-gastric junction carcinoma and gastric cancer
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Other
Interventions/Control_1 samples of endoscopic biopsy from patients with esophago-gastric cancer
Interventions/Control_2 samples of endoscopic biopsy from patients with gastric cancer
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
90 years-old >=
Gender Male and Female
Key inclusion criteria esophago-gastric cancer and gastric cancer without current Helicobacter pylori infection
Key exclusion criteria antibiotics/ steroid/ immunosuppressive medicine within one month
history of chemo/ chemo-radiation treatment
history of surgery for upper abdomen
contraindication of endoscopic biopsy
pregnancy/ mental disorder
severe systemic disease
others
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tomoyuki
Middle name
Last name Koike
Organization Tohoku University Hospital
Division name Gastroenterology
Zip code 981-8574
Address 1-1 Seiryo-cho Aoba-ku Sendai
TEL 81227177171
Email kaname.uno.c3@tohoku.ac.jp

Public contact
Name of contact person
1st name Kaname
Middle name
Last name Uno
Organization Tohoku University Hospital
Division name Gastroenterology
Zip code 981-8574
Address 1-1 Seiryo-cho Aoba-ku Sendai
TEL 819075640355
Homepage URL
Email kaname.uno.c3@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University Hospital
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
Address 1-1 Seiryo-cho Aoba-ku Sendai
Tel 81227177171
Email kaname.uno.c3@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
2021 Year 03 Month 17 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 Preinitiation
Date of protocol fixation
2020 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2025 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 07 Day
Last modified on
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047981

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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