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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009320
Receipt No. R000009602
Scientific Title Clinicopathological features of small invasive colorectal cancers which are 2cm or less
Date of disclosure of the study information 2012/11/12
Last modified on 2013/06/24

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Basic information
Public title Clinicopathological features of small invasive colorectal cancers which are 2cm or less
Acronym Clinicopathological features of small invasive colorectal cancers which are 2cm or less
Scientific Title Clinicopathological features of small invasive colorectal cancers which are 2cm or less
Scientific Title:Acronym Clinicopathological features of small invasive colorectal cancers which are 2cm or less
Region
Japan

Condition
Condition Colorectal cancers
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinicopathological features of small colorectal cancers which are 2cm or less
Basic objectives2 Others
Basic objectives -Others Analytic epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of distal metastasis of T2-T4 small colorectal cancers which are 2cm or less
Key secondary outcomes 1. To clarify clinicopathological features of T2-T4 colorectal cancers according to their macroscopic forms.
2. To clarify clinicopathological feature of T2-T4 small colorectal cancers
3. To clarify clinicopathological feature of T1 colorectal 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 Histologically proven T2-T4 colorectal cancers (=<4cm) whose nodal and distant metastasis can be predicted by pathological specimens, CT, MRI, or PET

Key exclusion criteria Synchronous or metachronous cancers

Colorectal cancers whose distant metastasis can not predicted

Colitic cancer
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ei Kudo
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumio Ishida
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address
TEL
Homepage URL
Email fumio182@med.showa-u.ac.jp

Sponsor
Institute Digetive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization Japanese Society for Cancer of the Colon and Rectum
Organization
Division
Category of Funding Organization Other
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 昭和大学横浜市北部病院 消化器センター(神奈川県)
昭和大学横浜市北部病院 病理診断科(神奈川県)         
愛知県立がんセンター中央病院 消化器外科(愛知県) 
秋田赤十字病院 消化器病センター(秋田県) 
大阪医科大学附属病院 消化器外科(大阪府)
大阪大学消化器 外科(大阪府)          
癌研有明病院 内視鏡診療部(東京都) 
北里大学病院 消化器外科(神奈川県)   
九州大学病院別府病院 外科(大分県)   
杏林大学医学部附属病院 病理部(東京都)   
久留米大学医学部 消化器病センター 内視鏡治療部門(福岡県)
神戸大学大学院医学研究科 消化器内科学分野(兵庫県)
国立がん研究センター中央病院 消化管内視鏡科(東京都) 
国立がん研究センター東病院 消化管内視鏡科(千葉県) 
札幌厚生病院 第一消化器科(北海道)  
佐野病院(兵庫県) 
静岡県立がんセンター 大腸外科(静岡県)   
高野病院(熊本県)                      
帝京大学医学部附属病院 外科(東京都)       
東京大学医学部附属病院 大腸・肛門外科(東京都)
東邦大学医療センター大橋病院 外科(東京都) 
都立駒込病院 外科(東京都)       
新潟大学第一病理(新潟県)  
新潟大学第一外科 (新潟県)
広島大学 内視鏡診療科(広島県)      
兵庫医大 下部消化管外科(兵庫県)   
福岡大学筑紫病院(福岡県)            
福島県立医科大学会津医療センター準備室(福島県)    

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 12 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 Enrolling by invitation
Date of protocol fixation
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
2013 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information multicenter retrospective study

Management information
Registered date
2012 Year 11 Month 12 Day
Last modified on
2013 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009602

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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