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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001980
Receipt No. R000002416
Scientific Title Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Date of disclosure of the study information 2009/05/18
Last modified on 2017/07/11

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Basic information
Public title Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Acronym Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Scientific Title Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Scientific Title:Acronym Randomized Controlled trial to evaluate the effectiveness of total colonoscopy in colorectal cancer screening
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Laboratory medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To verify effectiveness of total colonoscopy compared to fecal occult blood test in colorectal cancer screening
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mortality rate of colorectal cancer
Key secondary outcomes Sensitivity and specificity of colorectal cancer, cumulative incidence rate of advanced colorectal cancer, and cumulative incidence rate of invasive colorectal cancer

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Fecal occult blood test added to total colonoscopy
Interventions/Control_2 Fecal occult blood test
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria 1.40 years to 74 years when registered
2.Signed the informed consent to participate in the study
Key exclusion criteria 1.History of colorectal cancer
2.Familial adenomatous polyposis, family history of hereditary non-polyposis colorectal cancer and inflammatory bowel disease (ulcerative colitis and crohn' s disease)
3.Malignant disease other colorectal cancer within 5 years
4.In severe condition, who are expected to live for 5 years
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin-ei Kudo
Organization Showa University Northern Yokohama Hospital
Division name Digestive Disease Center
Zip code
Address 35-1 Chuo Chigasaki Tsuzuki-ku Yokohama-city Kanagawa Japan
TEL 045-945-0686
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Saito
Organization National Cancer Center
Division name Research Center for Cancer Prevention and Screening
Zip code
Address 5-1-1 Tsukiji Chuo-ku Tokyo Japan
TEL 03-3542-2511
Homepage URL
Email hrsaito@ncc.go.jp

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

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Cancer Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 仙北市健康管理センター
大仙市健康増進センター
仙北市立角館総合病院

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 18 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
2009 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 18 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002416

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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