UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 09 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012033