UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010491 |
|---|---|
| Receipt number | 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 18:43:34 |
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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
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
papaiasango88185515@yahoo.co.jp
Sponsor or person
Institute
Digestive Disease Center,Showa University Nortern Yokohama Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012267
