Concordance study between Guardant360 and RASKET-B(MEBGEN) of RAS/BRAF evaluation in colorectal cancer. (GOZILA additional study).

Concordance study between Guardant360 and RASKET-B(MEBGEN) of RAS/BRAF evaluation in colorectal cancer. (GOZILA additional study). - GOZILA-RAS/BRAF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046220

Enrollment

350

Registered

2021-12-01

Start date

2021-12-13

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 colorectal cancers.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Colorectal cancer patients who participate in GOZILA study between August 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 RAS/BRAF status by RASKET-B kit (MEBGEN) are available.

Exclusion criteria

Exclusion criteria: Patients who are inappropriate to participate in this study for any reasons. Patients who have been treated with anti-EGFR antibody at the time of first collecting blood.

Design outcomes

Primary

Measure	Time frame
Overall percent agreement (OPA), positive percent agreement (PPA), and negative percent agreement (NPA) of RAS mutations by Guardant360 in comparison with those assessed by RASKET-B. OPA, PPA, NPA of BRAF V600E mutations by Guardant360 in comparison with those assessed by RASKET-B.	—

Secondary

Measure	Time frame
1.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations evaluated under the effect of extravasation of ctDNA with different threshold settings for Max MAF (Mutant Allelic Fraction) values. 2.The concordance rate between Guardant360 and RASKET-B per variant in RAS mutation-positive patients. 3.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations in the drug-naive and drug-treated groups, respectively. 4.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations by metastatic organs.	—

Measure

Time frame

1.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations evaluated under the effect of extravasation of ctDNA with different threshold settings for Max MAF (Mutant Allelic Fraction) values. 2.The concordance rate between Guardant360 and RASKET-B per variant in RAS mutation-positive patients. 3.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations in the drug-naive and drug-treated groups, respectively. 4.The concordance rate between Guardant360 and RASKET-B for RAS and BRAF mutations by metastatic organs.

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Countries

Japan

Contacts

Public ContactYu Aoki

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

yuaoki2@east.ncc.go.jp04-7133-1111

Outcome results