UMIN-CTR Clinical Trial

Basic information
Public title	The clinical study of the usefulness of Linked Color Imaging(LCI) in colonoscopy.
Acronym	The clinical study of the usefulness of Linked Color Imaging(LCI) in colonoscopy.
Scientific Title	The clinical study of the usefulness of Linked Color Imaging(LCI) in colonoscopy.
Scientific Title:Acronym	The clinical study of the usefulness of Linked Color Imaging(LCI) in colonoscopy.
Region	Japan

Condition
Condition	colon polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare ADR/AMR in LCI/WLI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adenoma detection rate
Key secondary outcomes	adenoma miss rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	LCI group
Interventions/Control_2	WLI group
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	patient undergoing colonoscopy
Key exclusion criteria	1)Patients whose risk of performing endoscopy exceeds usefulness 2)IBD 3)polyposis
Target sample size	780

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Yamamura
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	052-741-2172
Email	tyamamura@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Suzuki
Organization	Nagoya University Hospital
Division name	Department of Endoscopy
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi
TEL	052-741-2172
Homepage URL
Email	h-suzuki@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
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	Nagoya University Hospital
Address	65 Tsurumai-cho, Showa-ku, Nagoya,Aichi
Tel	052-741-2172
Email	ethic@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	2017 Year 05 Month 01 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	780
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	2017 Year 03 Month 08 Day
Date of IRB	2017 Year 06 Month 07 Day
Anticipated trial start date	2017 Year 06 Month 07 Day
Last follow-up date	2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 01 Day
Last modified on	2021 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030286