UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006206 |
|---|---|
| Receipt number | R000007338 |
| Scientific Title | Effects of Helicobacter pylori eradication on the development of metachronous gastric cancer after endoscopic treatment: Analysis of molecular alterations by a randomized controlled trial |
| Date of disclosure of the study information | 2011/08/21 |
| Last modified on | 2015/12/25 18:51:22 |
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Basic information
Public title
Effects of Helicobacter pylori eradication on the development of
metachronous gastric cancer after endoscopic treatment:
Analysis of molecular alterations by a randomized controlled trial
Acronym
H. pylori eradication and gastric cancer
Scientific Title
Effects of Helicobacter pylori eradication on the development of
metachronous gastric cancer after endoscopic treatment:
Analysis of molecular alterations by a randomized controlled trial
Scientific Title:Acronym
H. pylori eradication and gastric cancer
Region
| Japan |
Condition
Condition
Early gastric cancer or adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the changes of molecular markers related to carcinogenesis in intestinal metaplasia (IM) by an open-label, randomized controlled trial (RCT) of H. pylori treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of biomarkers related to carcinogenesis are evaluated at baseline and 1-yr after intervention with/without H. pylori eradication
Primary endpoint: Change of microsatellite instability
Key secondary outcomes
Secondary endpoint: Changes of promoter hypermethylation of some tumor-related genes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
H. pylori un-eradicated group
Interventions/Control_2
H. pylori eradicated group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The indications for ESD for gastric neoplasms such as intramucosal gastric cancer and adenoma; (1) intramucosal papillary, well- or moderately-differentiated tubular adenocarcinoma of any size without ulceration, (2) intramucosal differentiated-type adenocarcinoma of less than 3 cm with an ulcer scar, (3) submucosal invasive cancer limited to 500 micrometer or less in invasion depth and differentiated-type adenocarcinoma of less than 3 cm without an ulcer scar and venous/lymphatic invasion
Key exclusion criteria
(1)Patients with malignancy in other organs
(2)Patients with having allergy to drugs used for H. pylori eradication
(3)Past episode of H. pylori treatment
(4)Patients with regularly taking non-steroidal anti-inflammatory drugs
(5)Patients with having a past history of esophagectomy or gastrectomy
(6)Patients who have determined by
the physicians to have any reasons of unqualified
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6665
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Watari |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6662
Homepage URL
watarij@hyo-med.ac.jp
Sponsor or person
Institute
Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
兵庫医科大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26671747
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
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007338
| 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 |
