UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007608 |
|---|---|
| Receipt number | R000008952 |
| Scientific Title | Efficacy of magnifying optical diagnosis for colorectal lesions using Narrow-band imaging International Colorectal Endoscopic classification. |
| Date of disclosure of the study information | 2012/03/30 |
| Last modified on | 2014/12/13 12:29:39 |
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Basic information
Public title
Efficacy of magnifying optical diagnosis for colorectal lesions using Narrow-band imaging International Colorectal Endoscopic classification.
Acronym
Efficacy of magnifying optical diagnosis using NICE classification.
Scientific Title
Efficacy of magnifying optical diagnosis for colorectal lesions using Narrow-band imaging International Colorectal Endoscopic classification.
Scientific Title:Acronym
Efficacy of magnifying optical diagnosis using NICE classification.
Region
| Japan |
Condition
Condition
colorectal lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to examine whether magnification endoscopy is useful for the optical diagnosis of colorectal lesions using NICE classification
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
High confidence rate of NBI with magnification for that of NBI without magnification
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who underwent total colonoscopy with magnification.
Key exclusion criteria
patient who had no polyp and only large polyps the size of which are over 10mm
Target sample size
313
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yasushi sano |
Organization
sano hospital
Division name
gastrointestinal center
Zip code
Address
2-5-1 shimizugaoka, tarumi-ku, kobe, hyogo,Japan
TEL
078-785-1000
ys_endoscopy@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | mineo iwatate |
Organization
sano hospital
Division name
gastrointestinal center
Zip code
Address
2-5-1 shimizugaoka, tarumi-ku, kobe, hyogo,Japan
TEL
078-785-1000
Homepage URL
m.iwatate15@gmail.com
Sponsor or person
Institute
sano hospital
Institute
Department
Personal name
Funding Source
Organization
sano 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
佐野病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2012 | Year | 03 | Month | 29 | Day |
Last modified on
| 2014 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008952
