UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001642 |
|---|---|
| Receipt number | R000001681 |
| Scientific Title | Multi-center study of recurrence and complications of endoscopic resection for colorectal tumors larger than 20mm in diameter -a prospective study - |
| Date of disclosure of the study information | 2009/01/16 |
| Last modified on | 2009/01/16 23:34:03 |
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Basic information
Public title
Multi-center study of recurrence and complications of endoscopic resection for colorectal tumors larger than 20mm in diameter -a prospective study -
Acronym
Multi-center study of recurrence and complications of endoscopic resection for colorectal tumors larger than 20mm in diameter
Scientific Title
Multi-center study of recurrence and complications of endoscopic resection for colorectal tumors larger than 20mm in diameter -a prospective study -
Scientific Title:Acronym
Multi-center study of recurrence and complications of endoscopic resection for colorectal tumors larger than 20mm in diameter
Region
| Japan |
Condition
Condition
colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the residual/ local recurrenceand perforation rate of endoscopic resection for colorectal tumors larger than 20mm in diameter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
residual/ local recurrence rate after endoscopic resection, perforation rate
Key secondary outcomes
analysis of the reasons and clinicopathologic features for residual/ local recurrence and perforation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
perforation (+)
perforation (-)
Interventions/Control_2
bleeding after endoscopic resection (+)
bleeding after endoscopic resection (-)
Interventions/Control_3
6~12 month after endoscopic resection
residual tumor (+)
residual tumor (-)
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 have resected colorectal tumors larger than 20mm in diameter by endoscopic resection in agreement with informed consent
Key exclusion criteria
Patients in disagreement with informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Tanaka |
Organization
Hiroshima University
Division name
Department of Endoscopy
Zip code
Address
1-2-3 Kasumi Minamiku Hiroshima, Japan
TEL
Homepage URL
colon@hiroshima-u.ac.jp
Sponsor or person
Institute
Japanese Society for Cancer of the Colon and Rectum
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Cancer of the Colon and Rectum
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2009 | Year | 01 | Month | 16 | 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
Date of protocol fixation
| 2008 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 16 | Day |
Last modified on
| 2009 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001681
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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