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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036361
Receipt No. R000041426
Scientific Title The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/31

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Basic information
Public title The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Acronym The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Scientific Title The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Scientific Title:Acronym The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the concordance of MSI status between testing using MSI panel (FALCO) and Bethesda panel.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity and Specificity
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Participate in GI-SCREEN MSI study
2) Patient who can provide written informed consent for secondary use of samples
3) Obtaining MSI status by MSI testing (FALCO)
4) Enough DNA samples
Key exclusion criteria 1)Patients who are unfit for the study as determined by the attending physician
Target sample size 435

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Yoshino
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwano-ha, Kashiwa-shi, Chiba, Japan
TEL 04-7133-1111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name Hiroya
Middle name
Last name Taniguchi
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwano-ha, Kashiwa-shi, Chiba, Japan
TEL 04-7133-1111
Homepage URL
Email hirtanig@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Ono PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization NCC IRB office
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.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

Other administrative information
Date of disclosure of the study information
2019 Year 04 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 24 Day
Date of IRB
2019 Year 03 Month 27 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is clinical validation study of MSI (FALCO) in comparison with MSI testing using Bethesda panel for colorectal cancer patients.

Management information
Registered date
2019 Year 03 Month 31 Day
Last modified on
2019 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041426

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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