UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015790 |
|---|---|
| Receipt number | R000018373 |
| Scientific Title | Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm |
| Date of disclosure of the study information | 2014/11/29 |
| Last modified on | 2016/01/07 17:01:08 |
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Basic information
Public title
Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm
Acronym
Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in PPI treatment of after ESD
Scientific Title
Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in the treatment of ulcers PPI after endoscopic treatment(ESD:endoscopic submucosal dissection) of gastric neoplasm
Scientific Title:Acronym
Study of the impact of CYP2C19 gene polymorphism and H.pylori eradication in PPI treatment of after ESD
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
When should Helicobacter pylori be eradicated in patients who underwent endoscopic submucosal dissection for gastric neoplasm to prevent complications?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the healing rates of artificial ulcer at 4 and 8 weeks late of ESD treatment
Key secondary outcomes
ESD-related complications such as bleeding or perforation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eradication of H. pylori before ESD treatment
Interventions/Control_2
eradication of H. pylori after ESD treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were diagnosed as early gastric cancer or gastric adenoma and are considered as the indication of ESD treatment
Key exclusion criteria
1.H.pylor-negative patients
2.Patiants with surgical history of stomach
3.patients who are pregnant or nursing
4.patients who are diagnosed as unsuitable for this trial by investigatior
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yashiro Yoshizawa |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-12-12 Sumiyoshi Naka-ku Hamamatsu Shizuoka Japan
TEL
053-474-2222
yashiro1224@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yashiro Yoshizawa |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-12-12 Sumiyoshi Naka-ku Hamamatsu Shizuoka Japan
TEL
053-474-2222
Homepage URL
yashiro1224@sis.seirei.or.jp
Sponsor or person
Institute
Department of Gastroenterology,Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Seirei Hamamatsu General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hamamatsu University school of Medicine
Name of secondary funder(s)
Hamamatsu University school of Medicine
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
| 2014 | Year | 11 | Month | 29 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 05 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 29 | Day |
Last modified on
| 2016 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018373
