UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011826 |
|---|---|
| Receipt number | R000013823 |
| Scientific Title | Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study. |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2015/03/21 18:48:48 |
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Basic information
Public title
Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.
Acronym
Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.
Scientific Title
Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.
Scientific Title:Acronym
Endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication: multicenter retrospective study.
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of annual endoscopic surveillance after curative endoscopic submucosal dissection for early gastric cancer and Helicobacter pylori eradication.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of metachronous gastric cancer which does not meet the criteria of ESD between patients with and without annual surveillance endoscopy.
Key secondary outcomes
The Clinicopathological features of metachronous gastric cancers.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endoscopic submucosal dissection for gastric cancer.
Pathologically diagnosed as curative resection.
Key exclusion criteria
Pathologically diagnosed as non-curative resection.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Doyama |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1, Kuratsukihigashi, Kanazawa city, Ishikawa 920-8530, Japan
TEL
076-237-8211
doyama.134@ipch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyoshi Nakanishi |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1, Kuratsukihigashi, Kanazawa city, Ishikawa 920-8530, Japan
TEL
076-237-8211
Homepage URL
nakanishi@ipch.jp
Sponsor or person
Institute
Ishikawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
石川県立中央病院(石川県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospective cohort study
Management information
Registered date
| 2013 | Year | 09 | Month | 20 | Day |
Last modified on
| 2015 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013823
