UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024747 |
|---|---|
| Receipt number | R000028470 |
| Scientific Title | Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study |
| Date of disclosure of the study information | 2016/11/08 |
| Last modified on | 2019/11/11 10:09:56 |
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Basic information
Public title
Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Acronym
Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Scientific Title
Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Scientific Title:Acronym
Endoscopic characterization of colorectal polyps by using blue laser imaging system: An international multi-center study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Colorectal polyps
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Evaluate the predictive validity and performance characteristics of the BLI system combined with the NICE and JNET classification systems for determination of polyp histology
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of performance to diagnose colorectal polyps by BLI
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with colorectal polyps who received colonoscopy based on national insurance
Key exclusion criteria
The patients who is judged as inappropriate by responsible doctor.
The patients who received chemotherapy or radiation therapy.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-8550
Address
65,Tsuruma-cho,Showa-ku,Nagoya-shi,Aichi
TEL
052-744-2601
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamamura |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-8550
Address
65,Tsuruma-cho,Showa-ku,Nagoya-shi,Aichi
TEL
052-744-2601
Homepage URL
tyamamu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine,Gastroenterology and Hepatology
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
Ethics Committee of Nagoya University
Address
65,Tsuruma-cho,Showa-ku,Nagoya-shi,Aichi
Tel
052-741-2111
ethics@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 09 | Month | 01 | Day |
Other
Other related information
The aim of this study is to evaluate the predictive validity and performance characteristics of the BLI system combined with the classification systems for determination of polyp histology.
Management information
Registered date
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2019 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028470
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
