Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Sysmex Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort A -Plasma samples (including DNA extracted from plasma samples) collected and stored from patients who have consented to secondary use of samples and data in the REMARRY study (UMIN000036424). -Plasma samples collected and stored from patients who confirmed progressive disease (PD) based on imaging or clinical PD before initiating subsequent treatment in the REMARRY study -Plasma samples that tested for RAS testing using the OncoBEAMTM RAS CRC kit with valid codon results at all codons in the REMARRY study -Plasma samples with a stored volume of more than 3 mL Cohort B -Plasma samples collected and stored from patients who have consented to secondary use of samples and data in the Lung mets shedding study (UMIN000045411) -Plasma samples that tested for RAS testing using the OncoBEAMTM RAS CRC kit with valid results at all codons in the Lung mets shedding study -Plasma samples with a stored volume of more than 3 mL
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of both KRAS and NRAS gene exon 2, 3 and 4 mutations between Test method and Reference method | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall percent agreement (OPA) between Test method and Reference method 2. Positive predictive value (PPV) and negative predictive value (NPV) between Test method and Reference method 3. Codon-based concordance rate between Test method and Reference method in RAS mutation-positive cases 4. MAF correlation between Test method and Reference method in RAS mutation-positive cases | — |
Countries
Japan
Contacts
Public ContactMasahiro Nishida
Sysmex Corporation Medical & Scientific Affairs
Outcome results
None listed