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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020277
Receipt No. R000023409
Scientific Title Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker
Date of disclosure of the study information 2015/12/19
Last modified on 2020/06/22

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Basic information
Public title Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker
Acronym Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker(Oshima Study)
Scientific Title Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker
Scientific Title:Acronym Field construction for diagnosis tool inspection of colorectal cancer and precancerous lesions using newly developed biomarker(Oshima Study)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We carry out the screening colonoscopy and perform an evaluation the effectiveness of the newly developed biomarker by using blood and stool sample.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic sensitivity, specificity, PPV, NPV and overall accuracy of the FIT and newly developed biomarker for colorectal cancer and precancerous lesions (so called advanced adenoma, >10mm, HGD).
Key secondary outcomes Safety and effectiveness of screening colonoscopy(complication rate, CRC detection rate and adenoma detection rate: ADR).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Total colonoscopy, FIT and Blood test will be provided once for all participants.
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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Residents in Oshima-machi, Tokyo
Key exclusion criteria Non-assentor
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Takahisa
Middle name
Last name Matsuda
Organization National Cancer Center Hospital
Division name Cancer Screening Center
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tamatsud@ncc.go.jp

Public contact
Name of contact person
1st name Takahisa
Middle name
Last name Matsuda
Organization National Cancer Center Hospital
Division name Cancer Screening Center
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email tamatsud@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email tamatsud@ncc.go.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 国立がん研究センター

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 19 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 1367
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
2015 Year 11 Month 26 Day
Anticipated trial start date
2015 Year 11 Month 26 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2030 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 19 Day
Last modified on
2020 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023409

Research Plan
Registered date File name
2019/06/27 ★大島STUDY 研究実施計画書(第13版).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/12/13 ★大島STUDY_miRNAデータ_20171213.xlsx


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