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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020849
Receipt No. R000024056
Scientific Title Role of cellular senescence in gastric carcinogenesis after eradication of Helicobacter pylori
Date of disclosure of the study information 2016/02/02
Last modified on 2018/01/19

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Basic information
Public title Role of cellular senescence in gastric carcinogenesis after eradication of Helicobacter pylori
Acronym Cellulat senescence for post-eradication gastric carcinogenesis
Scientific Title Role of cellular senescence in gastric carcinogenesis after eradication of Helicobacter pylori
Scientific Title:Acronym Cellulat senescence for post-eradication gastric carcinogenesis
Region
Japan

Condition
Condition early gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify a role of cellular senescence in gastric carcinogenesis after eradication
Basic objectives2 Others
Basic objectives -Others To elarify biological characteristics of gastric tissues taken by a Congo-red chromoendoscopic inspection
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes difference in the expression of senescence markers between the acid-secretion area and acid non-secretory area
Key secondary outcomes difference in histological features between the acid secretion area and acid non-secretory area

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 patients who were taken examination for early gastric cancer at our department
Key exclusion criteria 1) patients younger than 20 years old or older than 85 years old; 2) patients with history of chemotherapy, radiotherapy or upper abdominal surgery; 3) patients taking nonsteroidal anti-inflammatory drugs, antibiotics, or any anti-secretory drugs, such as proton pump inhibitors or H2 blockers; 4) patients with a serious general condition; 5) patients suffering from mental disorders; 6) patients who might be pregnancy; 7) patients with inappropriate biopsy specimens; and 8) patients who refused to participate in this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaname Uno
Organization Tohoku University
Division name Gastroenterology
Zip code
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
Middle name
Last name Kaname Uno
Organization Tohoku University
Division name Gastroenterology
Zip code
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 hospital, Division of Gastroenterology
Institute
Department

Funding Source
Organization Tohoku university hospital, Division of Gastroenterology
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
Address
Tel
Email

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
2016 Year 02 Month 02 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
It is hard to enroll the subjects into this study using a Congo-red endoscopy, so the numbers of them are not enough to investigate as a clinical study. However, we studied the characteriscics of the mucosa, non-cancerous/ cancerous mucosa after the eradication and non-cancerous/ cancerous mucosa with H.pylori, by various molecular biological methods, and then we demonstrated that the EMT marker induction in mucosa after eradication were different from those with H.pylori infection. These results were accepted by the medical journal. 
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
2014 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2017 Year 07 Month 10 Day
Date of closure to data entry
2017 Year 09 Month 15 Day
Date trial data considered complete
2017 Year 10 Month 26 Day
Date analysis concluded
2018 Year 01 Month 19 Day

Other
Other related information

Management information
Registered date
2016 Year 02 Month 02 Day
Last modified on
2018 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024056

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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