UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009979 |
|---|---|
| Receipt number | R000011689 |
| Scientific Title | Assessment of additional diagnostic value of endocytoscopy to magnifying chromoendoscopy for colorectal neoplasms; |
| Date of disclosure of the study information | 2013/02/07 |
| Last modified on | 2013/02/06 14:38:11 |
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Basic information
Public title
Assessment of additional diagnostic value of endocytoscopy to magnifying chromoendoscopy for colorectal neoplasms;
Acronym
Additional diagnostic value of endocytoscopy to magnifying chromoendoscopy
Scientific Title
Assessment of additional diagnostic value of endocytoscopy to magnifying chromoendoscopy for colorectal neoplasms;
Scientific Title:Acronym
Additional diagnostic value of endocytoscopy to magnifying chromoendoscopy
Region
| Japan |
Condition
Condition
Colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess additional diagnostic value of endocytoscopy to magnifying chromoendoscopy for colorectal neoplasms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic abilities of predicting massively invasive colorectal cancers by endocytoscopy and magnifying endoscopy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Observatin of sequential magnifying chromoendoscopy and endocytoscopy
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 consecutive patients who ere detected of a colorectal lesion with use of magnifying colonoscope with endocytoscopic capability.
Key exclusion criteria
Exclusion criteria are patients who are taking antiplatelet or anticoagulant agents and those with inflammatory bowel disease.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ei Kudo |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Mori |
Organization
Showa University Northern Yokohama Hospital
Division name
Digestive Disease Center
Zip code
Address
35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL
81-45-949-7693
Homepage URL
ibusiginjp@hotmail.com
Sponsor or person
Institute
Digestive Disease Center, 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
昭和大学横浜市北部病院消化器センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 07 | 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
| 2007 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | 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
Management information
Registered date
| 2013 | Year | 02 | Month | 06 | Day |
Last modified on
| 2013 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011689
| Research Plan | |
|---|---|
| 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 |
