UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Title of the study (Brief title)	Multicenter, randomized controlled trials on the usefulness of the Linked Color Imaging (LCI) in synchronous and metachronous gastric cancer detection.
Region	Japan

Condition
Condition	Surveillance of gastric cancer using endoscopy.
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study is to evaluate the usefulness of LCI for gastric cancer detection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of Gastric cancer by using LCI or white-light imaging (WLI).
Key secondary outcomes	Added efficacy of examination with LCI on the detection rate of gastric cancer in conventional WLI observation.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopic examination with LCI before conventional WLI observation.
Interventions/Control_2	Endoscopic examination with LCI after conventional WLI observation.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients before undergoing an endoscopic or surgical resection of early gastric cancer or Patients with follow-up after endoscopic resection of gastric cancer. 2. Patients can perform endoscopic biopsy when necessary. 3. Patients with informed consent.
Key exclusion criteria	1. Patients with advanced Gastric cancer. 2. The history of surgical gastric resection. 3. Patients has determined that inappropriate by principal investigator.
Target sample size	1000

Research contact person
Name of lead principal investigator	Tatsuya Yamaguchi
Organization	Faculty of Medicine, University of Yamanashi
Division name	First Department of Internal Medicine
Address	1110, Shimokato, Chuo, Yamanashi
TEL	055-273-1111
Email	ytatsuya@yamanashi.ac.jp

Public contact
Name of contact person	Tatsuya Yamaguchi
Organization	Faculty of Medicine, University of Yamanashi
Division name	First Department of Internal Medicine
Address	1110, Shimokato, Chuo, Yamanashi
TEL	055-273-9584
Homepage URL
Email	ytatsuya@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	University of Yamanashi
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 29 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 06 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 06 Month 28 Day
Last modified on	2016 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026414