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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018623
Receipt No. R000021551
Scientific Title Examination about the subclassification of the EC2 findings in the colorectal lesions.
Date of disclosure of the study information 2015/08/11
Last modified on 2019/08/25

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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/ctr_e/ctr_view.cgi?recptno=R000021551

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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