UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038117
Receipt No. R000043448
Scientific Title Comparison of diagnostic accuracy of endoscopic diagnosis (EC, pit pattern, NBI) in low grade adenoma
Date of disclosure of the study information 2019/11/01
Last modified on 2019/09/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.