UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008635 |
|---|---|
| Receipt number | R000010148 |
| Scientific Title | Long-term outcomes after resection for colonic and rectal types of submucosal invasive colorectal cancer |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2014/12/04 14:21:46 |
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Basic information
Public title
Long-term outcomes after resection for colonic and rectal types of submucosal invasive colorectal cancer
Acronym
SM long-term study
Scientific Title
Long-term outcomes after resection for colonic and rectal types of submucosal invasive colorectal cancer
Scientific Title:Acronym
SM long-term study
Region
| Japan |
Condition
Condition
submucosal, invasive colorectal cance
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the differences in long-term outcomes for patients following treatment for colonic and rectal SM-CRC
Basic objectives2
Others
Basic objectives -Others
evaluation of long-term
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recurrence rates, 5-year disease free survival (DFS), and 5-year overall survival (OS)
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients treated for submucosal invasive colorectal cancer with endoscopic or Surgical resection as the first line of treatment
Key exclusion criteria
familial adenomatous polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), or inflammatory bowel disease (IBD); presence of active, malignant diseases in any other organs; presence of synchronous or metachronous, advanced colorectal cancer; follow-up periods of <1 year
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
hikemats@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ikematsu |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology & Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
hikemats@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
health and labour sciences research grants
Organization
Division
Category of Funding Organization
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
国立がん研究センター中央病院（東京都）、国立がん研究センター東病院（千葉県）、静岡県立がんセンター（静岡県）、佐久総合病院（長野県）、栃木県立がんセンター（栃木県）、藤井隆広クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 08 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The clinical records of SM-CRC patients treated at 6 institutions between January 2000 and December 2007 were reviewed.
Recurrence rates, 5-year disease-free survival rates, and 5-year overall survival rates were retrospectively assessed.
Management information
Registered date
| 2012 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010148
