UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042043 |
|---|---|
| Receipt number | 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 | 2024/02/15 12:35:58 |
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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
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
kaname.uno.c3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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
| 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=R000047981
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
