UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009360 |
|---|---|
| Receipt number | R000010999 |
| Scientific Title | The study on the prevention of recurrence of early gastric cancer after endoscopic therapy |
| Date of disclosure of the study information | 2013/01/10 |
| Last modified on | 2016/11/14 22:27:37 |
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Basic information
Public title
The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Acronym
The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Scientific Title
The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Scientific Title:Acronym
The study on the prevention of recurrence of early gastric cancer after endoscopic therapy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate risk factors and appropriate follow-up period for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess risk factors for metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Key secondary outcomes
To assess the time of onset of metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The relationship of degree of gastric mucosal atrophy on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
Interventions/Control_2
The relationship between successful H.pylori eradication arm and unsuccessful H.pylori eradication arm on metachronous gastric cancer after endoscopic treatment for early gastric cancer.
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 after endoscopic treatment for early gastric cancer
Key exclusion criteria
Patients after gastrectomy
Patinets without curative resection of gastric cancer endoscopically
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
nonaka_taka@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Takashi |
Organization
Yokohama City University Hospital
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
nonaka_taka@yahoo.co.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010999
