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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040690
Receipt No. 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 2021/01/13

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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
Institute Japan Gastroenterological Endoscopy Society
Institute
Department

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 Preinitiation
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
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.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


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