UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040690
Receipt number R000046442
Scientific Title A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)
Date of disclosure of the study information 2020/06/08
Last modified on 2022/07/25 20:52:16

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Basic information

Public title

A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)

Acronym

A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)

Scientific Title

A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)

Scientific Title:Acronym

A Japanese multicenter observational study to evaluate factors affecting colonoscopy outcomes (J-SCOUT study)

Region

Japan


Condition

Condition

Colorectal cancer, colorectal polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate factors affecting colonoscopy outcomes in Japan

Basic objectives2

Others

Basic objectives -Others

factor analysis

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

adenoma detection rate

Key secondary outcomes

polyp detection rate, invasive cancer detection rate, advanced neoplasia detection rate, sessile serrated lesion detection rate, neuroendocrine tumor detection rate, flat and depressed lesion detection rate, the total number of adenomas per colonoscopy, cecal intubation rate, and complication rate


Base

Study type

Observational


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

120 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Subjects who underwent colonoscopy from April 2010 to March 2020
(2) Subjects over 20 years old

Key exclusion criteria

(1) Those who refuse to participate
(2) Those who underwent colonoscopy during the period when the endoscopic database of each hospital is not in place
(3) Those who underwent colonoscopy within 6 months
(4) Those who underwent colonoscopy for the purpose of detailed examination or treatment of colorectal lesions that were already pointed out
(5) Those who diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
(6) Those who underwent colonoscopy as an emergent endoscopy
(7) Others

Target sample size

150000


Research contact person

Name of lead principal investigator

1st name Kiyohito
Middle name
Last name Tanaka

Organization

Japan Gastroenterological Endoscopy Society

Division name

Japan Endoscopy Database Project

Zip code

101-0062

Address

Shin-ochanomizu Urban Trinity Bldg. 4F, 3-2-1 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062, Japan

TEL

03-3525-4670

Email

seijin7705@gmail.com


Public contact

Name of contact person

1st name Takuji
Middle name
Last name Kawamura

Organization

Kyoto Second Red Cross Hospital

Division name

Department of Gastroenterology

Zip code

602-8026

Address

355-5, Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, JAPAN

TEL

075-231-5171

Homepage URL


Email

kawamurat@kyoto2.jrc.or.jp


Sponsor or person

Institute

Japan Gastroenterological Endoscopy Society

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Gastroenterological Endoscopy Society

Address

Shin-ochanomizu Urban Trinity Bldg. 4F, 3-2-1 Kandasurugadai, Chiyoda-ku, Tokyo 101-0062, Japan

Tel

03-3525-4670

Email

jges-rinri@jges.or.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

大阪国際がんセンター(大阪府)、尾田胃腸内科・内科(熊本県)、北里大学(神奈川県)、京都大学(京都府)、京都第二赤十字病院(京都府)、国立がん研究センター中央病院(東京都)、国立がん研究センター東病院(千葉県)、静岡医療センター(静岡県)、東京慈恵会医科大学葛飾医療センター(東京都)、東京大学(東京都)、京都府立医科大学(京都府)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 08 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

No longer recruiting

Date of protocol fixation

2020 Year 06 Month 08 Day

Date of IRB

2020 Year 06 Month 08 Day

Anticipated trial start date

2020 Year 06 Month 08 Day

Last follow-up date

2022 Year 06 Month 07 Day

Date of closure to data entry

2022 Year 06 Month 07 Day

Date trial data considered complete

2022 Year 06 Month 07 Day

Date analysis concluded

2025 Year 06 Month 07 Day


Other

Other related information

A multicenter observational study using large-scale endoscopy database


Management information

Registered date

2020 Year 06 Month 08 Day

Last modified on

2022 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046442


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name