UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010364 |
|---|---|
| Receipt number | R000012129 |
| Scientific Title | Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2013/03/29 23:20:10 |
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Basic information
Public title
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
Acronym
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
Scientific Title
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
Scientific Title:Acronym
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
Region
| Japan |
Condition
Condition
colorectal cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Recently,the existence of depressed-type early colorectal carcinomas has been revealed, and an increasing number of such lesions have been reported. Depressed-type lesions are considered to emerge directly from the normal epithelium not via adenomas. These are called "de novo" carcinomas. The aim is to clarify the clinicopathological features of depressed-type early colorectal carcinomas.
Basic objectives2
Others
Basic objectives -Others
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoscopic and clinicopathological features of depressed-type early colorectal carcinomas
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A total of 16071 colorectal carcinomas excluding advanced carcinomas have been resected endoscopically or surgically in our center from April 2001 to Jun 2011.
Of these, 717 submucosal invasive colorectal carcinomas were included.
Key exclusion criteria
minor or those 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 Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki-chuo, tsuzuki-ku, Yokohama,
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
TEL
0459497000
Homepage URL
Sponsor or person
Institute
Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Northern 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
昭和大学横浜市北部病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 01 | 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 | 03 | 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
We analyzed the endoscopic and clinicopathological features
Management information
Registered date
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012129
