UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Novel Blue Laser Imaging for the Diagnosis of Colorectal Polyps
Title of the study (Brief title)	A Novel BLI for the Diagnosis of Colorectal Polyps
Region	Japan

Condition
Condition	colorectal polyps
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of BLI to colorectal polyps
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diagnostic accuracy
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a patient with neoplastic and non-neoplastic colorectal polyps
Key exclusion criteria	a case with severe general conditions
Target sample size	1000

Research contact person
Name of lead principal investigator	Naohisa Yoshida
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address
TEL	075-251-5519
Homepage URL
Email

Sponsor
Institute	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
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	2013 Year 03 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 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	random sampling

Management information
Registered date	2013 Year 03 Month 03 Day
Last modified on	2018 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011890