UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020849 |
|---|---|
| Receipt number | 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 13:40:09 |
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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
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
kaname-1@umin.ac.jp
Sponsor or person
Institute
Tohoku university hospital, Division of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024056
| 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 |
