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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042612
Receipt No. R000048600
Scientific Title The concordance study of MSI status between Guardant360 and MSI test kit (FALCO) (GOZILA additional study 01)
Date of disclosure of the study information 2020/12/01
Last modified on 2021/06/03

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Basic information
Public title The concordance study of MSI status between Guardant360 and MSI test kit (FALCO) (GOZILA additional study 01)
Acronym GOZILA-MSI
Scientific Title The concordance study of MSI status between Guardant360 and MSI test kit (FALCO) (GOZILA additional study 01)
Scientific Title:Acronym GOZILA-MSI
Region
Japan

Condition
Condition Patients with unresectable advanced / recurrent gastrointestinal / abdominal malignancies
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Pembrolizumab was approved along with a companion diagnostic, the MSI test kit (FALCO), for patients who have solid tumors with MSI-H in December 2018. In February 2020, Nivolumab was also approved along with the same companion diagnostic for MSI for patients who have CRC with MSI-H.
If this study shows acceptable concordance (OPA, >90; PPA, >70; NPA, >90) between Guardant360 and an MHLW approved diagnostics, MSI test kit (FALCO), Guardant360 would be allowed to be used as a companion diagnostics for immune checkpoint inhibitors as well as a panel test for cancer-associated genetic alterations in a clinical setting. In addition, because Guardant360 uses whole blood as a specimen, not tissue samples, it could be used for the patients who are unable to perform tissue testing. The study results will be used for regulatory submission of Guardant360 in Japan.
Basic objectives2 Others
Basic objectives -Others If this study shows acceptable concordance (OPA, >90; PPA, >70; NPA, >90) between Guardant360 and an MHLW approved diagnostics, MSI test kit (FALCO), Guardant360 would be allowed to be used as a companion diagnostics for immune.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall percent agreement (OPA), positive percent agreement (PPA), and negative percent agreement (NPA) of MSI status assessed by Guardant360 in comparison with those assessed by the MSI test kit (FALCO) and the RUO/IUO MSI kit in GI-SCREEN MSI
Key secondary outcomes OPA, PPA, and NPA of MSI status assessed by Guardant360 in comparison with those obtained with (1) the MSI assay kit (FALCO), (2) the RUO/IUO MSI kit in GI-SCREEN MSI.
OPA, PPA, and NPA of MSI status assessed by Guardant360 in comparison with those o assessed by the MSI test kit (FALCO) and RUO/IUO MSI kit in GI-SCREEN MSI with different threshold settings for Max MAF (Mutant Allelic Fraction) values (0.1%, 0.2% and 1.0%).
Data analysis will be conducted using the following two cohorts:
(1) patients with solid tumors
(2) patients with CRC
Data analysis will be conducted using the following two cohorts:

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) Patients who participate in GOZILA study between November 1st, 2018 and February 29, 2020 and can provide written informed consent for secondary use
2) Patients whose Guardant360 results are available for analysis in this study
3) Patients whose MSI status by MSI test kit (FALCO) or MSI status from GI-SCREEN MSI study are available for analysis in this study
Key exclusion criteria Patients who are inappropriate to participate in this study for any reasons
Target sample size 2385

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterrelogy and Gastroint estinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa Chiba
TEL 04-7133-1111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterrelogy and Gastroint estinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa Chiba
TEL 04-7133-1111
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Guardant Health Japan Corp.
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 Institutional Review Board
Address 5-1-1, tsukiji, tyuo-ku, Tokyo
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
2020 Year 12 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 No longer recruiting
Date of protocol fixation
2020 Year 08 Month 12 Day
Date of IRB
2020 Year 10 Month 15 Day
Anticipated trial start date
2020 Year 10 Month 16 Day
Last follow-up date
2020 Year 11 Month 27 Day
Date of closure to data entry
2020 Year 11 Month 27 Day
Date trial data considered complete
2020 Year 11 Month 30 Day
Date analysis concluded
2021 Year 01 Month 21 Day

Other
Other related information A retrospective observational study using the date or information GOZILA Study
October 2020 to September, 2022

Management information
Registered date
2020 Year 12 Month 01 Day
Last modified on
2021 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048600

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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