UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Title of the study (Brief title)	The utility of Blue LASER Imaging for the diagnosis of gastric cancer
Region	Japan

Condition
Condition	early gastric cancer and suspicious of early gastric cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness of detection ability of early gastric cancer by Blue LASER Imaging. To clarify the usefulness of the diagnosis of magnified endoscopic images with Blue LASER Imaging for early gastric cancer or suspicious of early gastric cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection ability of early gastric cancer by Blue LASER Imaging and diagnosis ability of magnified endoscopic images by Blue LASER Imaging according to VS classification
Key secondary outcomes	Degree of diagnosis agreement according to VS classification of magnified endoscopic images with Blue LASER Imaging and narrow band imaging

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Blue LASER Imaging-white light imaging group
Interventions/Control_2	white light imaging-Blue LASER Imaging 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	Patients who have chronic atrophic gastritis, past history of gastric cancer or suspicious of gastric cancer
Key exclusion criteria	Patients who do not have chronic atrophic gastritis, past history of gastric cancer and suspicious of gastric cancer Patients whom a researcher judged to be inappropriate as a subject
Target sample size	600

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Osamu Dohi
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kawaramachi Hirokoji Kamigyo-ku, Kyoto
TEL	075-251-5519
Homepage URL
Email	osamu-d@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology
Name of secondary funｄer(s)

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	京都府立医科大学附属北部医療センター 京都府立医科大学

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 07 Month 30 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 30 Day
Last modified on	2018 Year 11 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013270