UMIN-CTR Clinical Trial

Basic information
Public title	Diagnostic efficacy for gastric cancer by Linked color image compare to White light image
Acronym	Diagnosis for gastric cancer by Linked color image
Scientific Title	Diagnostic efficacy for gastric cancer by Linked color image compare to White light image
Scientific Title:Acronym	Diagnosis for gastric cancer by Linked color image
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of diagnosis for gastric cancer by Linked color image compare to white light image
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison between white light image and Linked color image for visibility score, and detection rate
Key secondary outcomes	Accuracy, evaluation of characteristic of lesions which cannot be correctly diagnosed by white light image and Lincked color image, respectively

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	short movie of LCI
Interventions/Control_2	short movie of WLI
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	Patients who have lesions for treatment, and were referred to our hospital, and need ditail examination
Key exclusion criteria	1. dirty stomach 2. Remnant stomach 3. Gastric tube 4. Peptic ulcer scar 5. History of endoscopic treatment 6. No consent for sedation 7. Pregnant 8. Mental illness
Target sample size	95

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroyuki Osawa, M.D., Ph.D
Organization	Jichi medical University
Division name	Department of Internal Medicine, Division of Gastroenterology
Zip code
Address	3311-1, Yakushiji, shimotsuke, Tochigi
TEL	0285-58-7539
Email	osawa@jichi.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshimasa Miura, M.D.
Organization	Jichi Medical University
Division name	Department of Internal Medicine, Division of Gastroenterology
Zip code
Address	3311-1, Yakushiji, shimotsuke, Tochigi
TEL	0285-58-7539
Homepage URL
Email	y-miura@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	FUJIFILM MEDICAL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 Month 24 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 05 Month 19 Day
Date of IRB
Anticipated trial start date	2016 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 21 Day
Last modified on	2017 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032411

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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