UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038117
Receipt number 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 18:06:48

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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 or person

Institute

Digestive Disease Center, Showa University Northern Yokohama Hospital

Institute

Department

Personal name



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

Value
https://center6.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