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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010491
Receipt No. R000012267
Scientific Title The risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas
Date of disclosure of the study information 2013/04/20
Last modified on 2014/04/18

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Basic information
Public title The risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas
Acronym The risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas
Scientific Title The risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas
Scientific Title:Acronym The risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas
Region
Japan

Condition
Condition colorectal cancers
Classification by specialty
Gastroenterology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim to investigate the prognoses of patients suffering from SM colorectal cancers.
Basic objectives2 Others
Basic objectives -Others The aim is to clarify the risk factors for recurrence or distant metastases dealing with a large number of samples.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Long-term outcome of submucosal- invasive colorectal carcinomas
Key secondary outcomes risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A total of 17291 colorectal carcinomas excluding advanced cancers have been resected endoscopically or surgically in our center from April 2001 to Dec 2012.
Key exclusion criteria minor or who did not agree
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Mastudaira
Organization Showa University Nortern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1,Chigasaki-chuo,tsuzuki-ku,Yokohama
TEL 0459497000
Email papaiasango88185515@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Matsudaira
Organization Showa University Nortern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address Yokohama
TEL 045-949-7000
Homepage URL
Email papaiasango88185515@yahoo.co.jp

Sponsor
Institute Digestive Disease Center,Showa University Nortern Yokohama Hospital
Institute
Department

Funding Source
Organization Digestive Disease Center,Showa University Nortern Yokohama Hospital
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
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
2013 Year 04 Month 20 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 Preinitiation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospectively we analyze the risk factors for recurrence and distant metastasis of submucosal- invasive colorectal carcinomas

Management information
Registered date
2013 Year 04 Month 14 Day
Last modified on
2014 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012267

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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