UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006776 |
|---|---|
| Receipt number | R000008019 |
| Scientific Title | Long-term follow-up study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer |
| Date of disclosure of the study information | 2011/11/27 |
| Last modified on | 2012/02/07 20:39:03 |
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Basic information
Public title
Long-term follow-up study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer
Acronym
JGSG secondary gastric cancer follow-up study
Scientific Title
Long-term follow-up study of Helicobacter pylori Eradication after endoscopic resection of early gastric cancer
Scientific Title:Acronym
JGSG secondary gastric cancer follow-up study
Region
| Japan |
Condition
Condition
early stage of gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term inhibitory effects of H. pylori eradication on the development of metachronous gastric carcinomas after endoscopic resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Detection of secondary (metachronous) cancer at another site of the stomach
Key secondary outcomes
Recurrence of residual cancer at the resection site because of incomplete resection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
H. pylori eradication
Interventions/Control_2
No eradication
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients eligible for enrollment included those diagnosed with early gastric cancer, either newly diagnosed and planning to have endoscopic treatment or those in whom early gastric cancer had been resected and were in follow-up phase after endoscopic treatment.
Patients enrolled in the first trail.
Key exclusion criteria
Exclusion criteria were absence of an active H. pylori infection; development of another gastric cancer after endoscopic treatment prior to entry; and a history of gastric surgery.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Asaka |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
North 15, West 7, Kita-Ku, Sapporo, Hokkaido, JAPAN
TEL
+81-11-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu Kato |
Organization
Hokkaido University Hospital
Division name
Division of endoscopy
Zip code
Address
North 14, West 5, Kita-Ku, Sapporo, Hokkaido, JAPAN
TEL
011-716-1161
Homepage URL
http://www.jgsg.jp/
m-kato@med.hokudai.ac.jp
Sponsor or person
Institute
Japan Gast Study Group
Institute
Department
Personal name
Funding Source
Organization
Hiroshima Cancer Seminar Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
北海道大学病院
他全国50施設
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
http://www.jgsg.jp/
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Eradication of H. pylori prevented siginificantly the incidence of metachronous cancer after endoscopic resection for primary early gastric cancer.
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
| 2000 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 10 | Month | 01 | Day |
Other
Other related information
Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group: Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial. Lancet 372, 392-7, 2008
Management information
Registered date
| 2011 | Year | 11 | Month | 27 | Day |
Last modified on
| 2012 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008019
| 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 |
