UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031129 |
|---|---|
| Receipt number | R000035557 |
| Scientific Title | Assessment of additional diagnostic value of crystal violet staining with magnified endoscopy to narrow-band imaging magnified endoscopy for colorectal polyps: A multicenter prospective study |
| Date of disclosure of the study information | 2018/02/05 |
| Last modified on | 2022/02/06 19:55:20 |
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Basic information
Public title
Assessment of additional diagnostic value of crystal violet staining with magnified endoscopy to narrow-band imaging magnified endoscopy for colorectal polyps: A multicenter prospective study
Acronym
NBI-CV study
Scientific Title
Assessment of additional diagnostic value of crystal violet staining with magnified endoscopy to narrow-band imaging magnified endoscopy for colorectal polyps: A multicenter prospective study
Scientific Title:Acronym
NBI-CV study
Region
| Japan | Europe |
Condition
Condition
Colorectal polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the additional diagnostic value of CV-ME to NBI-ME (accurate diagnosis including qualitative diagnosis and depth of carcinoma diagnosis) for colorectal polyps.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy rate (additional diagnostic value of CV-ME to NBI-ME)
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
(1) Adults aged 20 years or above
(2) Cases in which written informed consent is obtained before resection or biopsy
(3) Cases in which colonoscopy is performed after approval of the ethics committee at the registration facilities
Key exclusion criteria
(1) Cases judged to be inappropriate by the examining physician
Target sample size
1170
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University
Division name
Department of Gastroenterology
Zip code
2608677
Address
Inohana 1-8-1, Chiba-City, 260-8670
TEL
043-226-2083
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University
Division name
Department of Gastroenterology
Zip code
2608677
Address
Inohana 1-8-1, Chiba-City, 260-8670
TEL
043-226-2083
Homepage URL
matsumura@chiba-u.jp
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Graduate School of Medicine, Chiba University,Chiba, Japan
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
Chiba University
Address
Inohana 1-8-1, Chiba-City, 260-8670
Tel
+81432227171
inohana-rinri@chiba-u.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
| 2018 | Year | 02 | Month | 05 | 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
| 2017 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 02 | Month | 03 | Day |
Last modified on
| 2022 | 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=R000035557
