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Recruitment status
Unique ID issued by UMIN UMIN000001642
Receipt No. 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

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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
Email

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
Email colon@hiroshima-u.ac.jp

Sponsor
Institute Japanese Society for Cancer of the Colon and Rectum
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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