UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027524 |
|---|---|
| Receipt number | R000031491 |
| Scientific Title | Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori. |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2017/05/29 11:24:08 |
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Basic information
Public title
Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.
Acronym
Research about the onset mechanism of the gastric cancer after the antimicrobial treatment.
Scientific Title
Research about the onset mechanism of the gastric cancer after the antimicrobial treatment for Helicobacter pylori.
Scientific Title:Acronym
Research about the onset mechanism of the gastric cancer after the antimicrobial treatment.
Region
| Japan |
Condition
Condition
Gstric cancer and chronic gastritis after the Helicobacter pylori antimicrobial treatment
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is intended to search the gene expression causing the map-like redness and a background gastric mucosa associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.
Basic objectives2
Others
Basic objectives -Others
We try to perform a genome-wide search using miRNA derived from exosome and to identify new biomarkers associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment by analyzing gene expression by microarray.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The gene expression causing the map-like redness and a background gastric mucosa associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.
Key secondary outcomes
New biomarkers associated with the second cancer outbreak after the Helicobacter pylori antimicrobial treatment.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients whom gastric cancer developed in after antimicrobial treatment for Helicobacter pylori and control group after antimicrobial treatment that matched the number of years,sex,age.
Key exclusion criteria
Exclusion criteria are history of gastrectomy, and patients with gastric cancer or other malignant lesions, pylori-positive,hemorrhagic diseases, cirrhosis or renal failure.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyosuke Goda |
Organization
Kawasaki Medical School
Division name
Division of Gastroenterology Department of Internal Medicine
Zip code
Address
577 Matsushima Kurashiki City Okayama Prefecture 701-0192 Japan
TEL
086-462-1111
gooooo_ddy@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyosuke Goda |
Organization
Kawasaki Medical School
Division name
Division of Gastroenterology Department of Internal Medicine
Zip code
Address
577 Matsushima Kurashiki City Okayama Prefecture 701-0192 Japan
TEL
086-462-1111
Homepage URL
gooooo_ddy@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
| 2017 | Year | 06 | Month | 01 | 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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will be approved by the Ethical Committee of Kawasaki Medical School.
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031491
