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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010278
Receipt No. R000012033
Scientific Title Diagnostic value of endocytoscopy in the colorectum: a retrospective analysis
Date of disclosure of the study information 2013/03/19
Last modified on 2019/10/01

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Basic information
Public title Diagnostic value of endocytoscopy in the colorectum: a retrospective analysis
Acronym Diagnostic value of endocytoscopy in the colorectum
Scientific Title Diagnostic value of endocytoscopy in the colorectum: a retrospective analysis
Scientific Title:Acronym Diagnostic value of endocytoscopy in the colorectum
Region
Japan

Condition
Condition Colorectal neoplasms
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess additional diagnostic value of endocytoscopy to magnifying chromoendoscopy for colorectal neoplasms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic abilities of predicting massively invasive colorectal cancers by endocytoscopy and magnifying endoscopy.


Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 Inclusion criteria are consecutive patients who ere detected of a colorectal lesion with use of magnifying colonoscope with endocytoscopic capability.
Key exclusion criteria Exclusion criteria are patients who are taking antiplatelet or anticoagulant agents and those with inflammatory bowel disease.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Shin-ei
Middle name
Last name Kudo
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL 045-949-7535
Email kudos@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Mori
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code 2248503
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
TEL 045-949-7535
Homepage URL
Email ibusiginjp@hotmail.com

Sponsor
Institute Digestive Disease Center, 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 Institutional Review Board
Address 35-1, Chigasakityuo, Tsuzuki-ku, Yokohama-shi
Tel 0459497000
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
2013 Year 03 Month 19 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 5000
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
2005 Year 04 Month 30 Day
Date of IRB
2013 Year 03 Month 29 Day
Anticipated trial start date
2005 Year 05 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
2021 Year 10 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a retrospective study.

Management information
Registered date
2013 Year 03 Month 19 Day
Last modified on
2019 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012033

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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