UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012387 |
|---|---|
| Receipt number | R000014485 |
| Scientific Title | An investigation into the diagnosis of invasion depth in colorectal tumors by morphological type using magnifying and ultra-high magnifying endoscopy. |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2014/11/23 10:05:10 |
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Basic information
Public title
An investigation into the diagnosis of invasion depth in colorectal tumors by morphological type using magnifying and ultra-high magnifying endoscopy.
Acronym
An investigation into the diagnosis of invasion depth in colorectal tumors by morphological type using magnifying and ultra-high magnifying endoscopy.
Scientific Title
An investigation into the diagnosis of invasion depth in colorectal tumors by morphological type using magnifying and ultra-high magnifying endoscopy.
Scientific Title:Acronym
An investigation into the diagnosis of invasion depth in colorectal tumors by morphological type using magnifying and ultra-high magnifying endoscopy.
Region
| Japan |
Condition
Condition
colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the diagnostic characteristics of magnifying and ultra-high magnifying endoscopy by morphological type of colorectal lesions and evaluated the diagnostic differences and clinical applicability of the technique.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in diagnostic accuracy by morphological type when performing magnifying and ultra-high magnifying endoscopy on colorectal tumors.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Inclusion criteria are colorectal lesions that could be observed under magnification with crystal violet endoscopic dying and under ultra-high magnification using endocytoscopy in patients treated at our facility between 2005 and 2013.
Key exclusion criteria
Exclusion criteria are patients who are taking antiplatelet or anticoagulant agents.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoki Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki Chio, Tsuzuki-ku, Yokohama, Japan
TEL
045-9457265
s6027@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoki Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasaki Chio, Tsuzuki-ku, Yokohama, Japan
TEL
045-9457265
Homepage URL
s6027@nms.ac.jp
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 11 | Month | 25 | 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
| 2005 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | 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
This study is a retrospective study.
Management information
Registered date
| 2013 | Year | 11 | Month | 23 | Day |
Last modified on
| 2014 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014485
