The concordance study of MSI status between Guardant360 and MSI test kit (FALCO) (GOZILA additional study 01)

The concordance study of MSI status between Guardant360 and MSI test kit (FALCO) (GOZILA additional study 01) - GOZILA-MSI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042612

Enrollment

2385

Registered

2020-12-01

Start date

2020-10-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with unresectable advanced / recurrent gastrointestinal / abdominal malignancies

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients who are inappropriate to participate in this study for any reasons

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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:	—

Measure

Time frame

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:

—

Countries

Japan

Contacts

Public ContactYoshiaki Nakamura

National Cancer Center Hospital East Department of Gastroenterrelogy and Gastroint estinal Oncology

yoshinak@east.ncc.go.jp04-7133-1111

Outcome results