UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of diagnostic accuracy of endoscopic diagnosis (EC, pit pattern, NBI) in low grade adenoma
Acronym	Comparison of diagnostic accuracy of endoscopic diagnosis (EC, pit pattern, NBI) in low grade adenoma
Scientific Title	Comparison of diagnostic accuracy of endoscopic diagnosis (EC, pit pattern, NBI) in low grade adenoma
Scientific Title:Acronym	Comparison of diagnostic accuracy of endoscopic diagnosis (EC, pit pattern, NBI) in low grade adenoma
Region	Japan

Condition
Condition	Colorectal adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate EC findings with type I pit mixed in slit-like lumen seen in colorectal adenoma and examined whether it is useful for the grading of dysplasia for diagnosing colorectal adenomas.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The diagnostic accuracy of low grade adenoma using EC normal pit (NP) sign in endoscopic images
Key secondary outcomes	Comparison of diagnostic accuracy in low grade adenoma between EC classification using EC NP sign and pit pattern / NBI (JNET classification)

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Lesions that could be treated with neoplastic lesions that could be observed by EC and pathologically examined
Key exclusion criteria	hyperplastic polyps, sessile serated adenoma / polyps, inflamatory polyp, juvenile polyps, ulcerative colitis, malignant lymphoma, and lesions with unreadable images.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Suzuki
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama 224-8503, Japan
TEL	+81-45-949-7000
Email	kenichi.suzuki.19860617@gmail.com

Public contact
Name of contact person	1st name Kenichi Middle name Last name Suzuki
Organization	Showa University Northern Yokohama Hospital
Division name	Digestive Disease Center
Zip code	2248503
Address	35-1 Chigasaki-Chuo, Tsuzuki-ku, Yokohama 224-8503, Japan
TEL	+81-45-949-7000
Homepage URL
Email	kenichi.suzuki.19860617@gmail.com

Sponsor
Institute	Digestive Disease Center, Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization	Showa University Northern Yokohama Hospital
Organization
Division
Category of Funding Organization	Self funding
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, Yokohama 224-8503, Japan
Tel	+81-45-949-7000
Email	kenichi.suzuki.19860617@gmail.com

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	2019 Year 11 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective investigation of neoplastic lesions observed by EC between May 2005 and March 2018 that can be examined pathologically by endoscopic resection. In this study, age, sex, treatment content, endoscopic image, histopathological diagnosis result, and chart number are used.

Management information
Registered date	2019 Year 09 Month 26 Day
Last modified on	2019 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043448