UMIN-CTR Clinical Trial

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
Email	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
Email	matsumura@chiba-u.jp

Sponsor
Institute	Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035557