UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009190 |
|---|---|
| Receipt number | R000010790 |
| Scientific Title | Multiple center cohort study to evaluate the efficacy and longtime prognosis of endoscopic sub mucosal dissection for gastro-intestinal tumor |
| Date of disclosure of the study information | 2012/10/25 |
| Last modified on | 2012/10/25 22:46:55 |
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Basic information
Public title
Multiple center cohort study to evaluate the efficacy and longtime prognosis of endoscopic sub mucosal dissection for gastro-intestinal tumor
Acronym
Cohort study to evaluate the efficacy and longtime prognosis of ESD for gastro-intestinal tumor
Scientific Title
Multiple center cohort study to evaluate the efficacy and longtime prognosis of endoscopic sub mucosal dissection for gastro-intestinal tumor
Scientific Title:Acronym
Cohort study to evaluate the efficacy and longtime prognosis of ESD for gastro-intestinal tumor
Region
| Japan |
Condition
Condition
gastro-intestinal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy, safety, clinical characteristics, prognosis and longtime prognosis of ESD for gastro-intestinal tumor.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5year overall survival rate(OS)
Key secondary outcomes
1) Enbloc resection rate
2) Curative resection rate
3) Complication rate
4) Local/residual recurrence
5) Metastatic/residual recurrence
6) Metachronous double cancers rate
7) Disease free survival rate, Disease free metastatic rate
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
Written informed consent from patient going to undergo ESD or their parents or their proxy.
Key exclusion criteria
Not written informed consent or not going to undergo ESD.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto |
Organization
Kyushu University Hospital
Division name
Gastroenterology
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Matsumoto, Moriyama tomohiko, Ema Washio |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5261
Homepage URL
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
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
九州大学病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is multiple center cohort study to evaluate the efficacy and longtime prognosis of endoscopic sub mucosal dissection for gastro-intestinal tumor.
Management information
Registered date
| 2012 | Year | 10 | Month | 25 | Day |
Last modified on
| 2012 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010790
