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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024144
Receipt No. R000027798
Scientific Title Clinical evaluation study of newly developed microsatellite instability test kit
Date of disclosure of the study information 2016/09/23
Last modified on 2017/10/05

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Basic information
Public title Clinical evaluation study of newly developed microsatellite instability test kit
Acronym GI-SCREEN-CRC-MSI substudy 01
Scientific Title Clinical evaluation study of newly developed microsatellite instability test kit
Scientific Title:Acronym GI-SCREEN-CRC-MSI substudy 01
Region
Japan

Condition
Condition Advanced / recurrent colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Laboratory medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the concordance between the standard method of MSI test using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
Basic objectives2 Others
Basic objectives -Others To compare the positive and negative concordance rate between standard genetic tastings and a newly developed MSI test kit
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate sensitivity (positive concordance rate) and specificity (negative concordance rate) between the standard method using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients registered in GI-SCREEN CRC-MSI (UMIN000020437) and meet the following criteria;
1) Patients who agreed to the secondary usage of specimen when they agreed to GI-SCREEN CRC-MSI, and did not revoked their agreements.
2) Patients whose MSI status were decided by both tumor and normal samples in GI-SCREEN CRC-MSI
3) Sufficient quantity of DNA were extracted from patients' tumor sample for newly developed MSI test kit
Key exclusion criteria 1) Patients judged as inappropriate for this study by investigator
Target sample size 300

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

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

Sponsor
Institute FALCO biosystems Ltd.
Institute
Department

Funding Source
Organization FALCO biosystems 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 23 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 Completed
Date of protocol fixation
2016 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 10 Day

Other
Other related information Five mononucleotides microsatellite marker, NR21, BAT26, BAT25, NR24 and MONO27, were utilized by newly developed MSI test kit.

Management information
Registered date
2016 Year 09 Month 23 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027798

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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