UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042612 |
|---|---|
| Receipt number | 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 | 2022/10/05 16:47:12 |
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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
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
yoshinak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
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
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
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
2385
Results
ctDNA genotyping was able to detect MSI with high concordance to validated tissue-based MSI testing, especially in patients with tumors that have sufficient ctDNA shedding.
Results date posted
| 2022 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median (interquartile range) age was 63 (54 - 70) years, and 391 (59.2%) males and 270 (40.8%) females were included.
Participant flow
Of 2385 patients with advanced solid tumor enrolled in GOZILA between November 2018 and February 2020, 661 patients with both plasma and tissue testing for MSI were included.
Adverse events
Not applicable
Outcome measures
The OPA, PPA, and NPA were 98.2% (95% CI, 96.9-99.1%), 71.4% (95% CI, 47.8-88.7%), and 99.1% (95% CI, 98.0-99.7%), respectively. In patients whose plasma samples had ctDNA fraction >= 1.0%, the PPA was 100.0% (15/15; 95% CI, 78.2-100.0%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048600
