UMIN-CTR Clinical Trial

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

Condition
Condition	Superficial esophageal carcinoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the usefulness of detection ability of superficial esophageal cancer by Blue LASER Imaging.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection and diagnosis ability of superficial esophageal cancer by Blue LASER Imaging.
Key secondary outcomes	Degree of diagnosis agreement of endoscopic findings with Blue LASER Imaging and narrow band imaging

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	Patients who have superficial esophageal cancer.
Key exclusion criteria	Patients whom a researcher judged to be inappropriate as a subject.
Target sample size	25

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
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	京都府立医科大学

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 12 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 06 Month 10 Day
Anticipated trial start date	2015 Year 06 Month 11 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	Published
URL releasing results
Results
Other related information	Endoscopic films were reviewed retrospectively.

Management information
Registered date	2015 Year 06 Month 10 Day
Last modified on	2016 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020701