UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009320 |
|---|---|
| Receipt number | 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 | 2019/11/26 10:44:22 |
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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 | Shin-ei |
| Middle name | |
| Last name | Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
0459497000
kudos@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Ishida |
| Middle name | |
| Last name | Fumio |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
2248503
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
0459497000
Homepage URL
fumio182@med.showa-u.ac.jp
Sponsor or person
Institute
Digetive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
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
Institutional review board, Showa University Northern Yokohama Hospital
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
Tel
0459497000
irb02syo@ofc.showa-u.ac.jp
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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 26 | 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
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009602
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
