UMIN-CTR Clinical Trial

Basic information
Public title	Examination about the subclassification of the EC2 findings in the colorectal lesions.
Acronym	Examination about the subclassification of the EC2 findings in the colorectal lesions.
Scientific Title	Examination about the subclassification of the EC2 findings in the colorectal lesions.
Scientific Title:Acronym	Examination about the subclassification of the EC2 findings in the colorectal lesions.
Region	Japan

Condition
Condition	colorectal neoplasms
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the observation of the colorectal lesions using the EC classification by endocytoscopy, we examine subclassification to improve the endoscopic predictive diagnosis of the grade of the adenoma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Utility of the endoscopic diagnosis by subclassifying EC classifications more
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	Colorectal lesions which we could conduct ultra-high magnifying endoscope observation from 2005 through 2015 in CM (crystal violet, mathylene blue) double staining and were resectable, in particular the lesions which were diagnosed as EC2.
Key exclusion criteria	Exclusion criteria are patients who are taking antiplatelet or anticoagulant agents.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Toyki Middle name Last name Kudo
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-001
Address	35-1, Chigasaki Chuo, Tsuzuki-ku, Yokohama, Japan
TEL	045-945-7265
Email	s6027@nms.ac.jp

Public contact
Name of contact person	1st name Toyoki Middle name Last name Kudo
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	224-0001
Address	35-1, Chigasaki Chuo, Tsuzuki-ku, Yokohama, Japan
TEL	045-945-7265
Homepage URL
Email	s6027@nms.ac.jp

Sponsor
Institute	Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Showa University Northern Yokohama Hospital
Address	35-1 Chigasaki-chuo, Tsuzuki-ku
Tel	045-949-7000
Email	irb02syh@ofc.showa-u.ac.jp

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	2015 Year 08 Month 11 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	2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date	2015 Year 08 Month 11 Day
Last follow-up date	2017 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a case-control study. The recruitment of subjects is all patients in line with criteria for selection in our institution consultation patients. A measurement item to cast into analysis is EC findings.

Management information
Registered date	2015 Year 08 Month 10 Day
Last modified on	2019 Year 08 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021551