Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Sysmex corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically confirmed primary colorectal adenocarcinoma 2)Patients aged 20 or older at the time of the informed consent 3)Patients who signed informed consent form 4)Patients whose blood collection is possible before a treatment start 5)Patients confirmed Stage4 colorectal cancer by imaging findings 6)Patients with no previous chemotherapy, or patients whose PD or clinical PD was confirmed before starting next treatment
Exclusion criteria
Exclusion criteria: 1)Patients judged ineligible to participate in the study 2)Patients registered to the study in the past 3)Patients with a history of multiple cancer or with a comorbid multiple cancer 4)Patients with synchronous or metachronous (a disease-free interval of five years or shorter) double cancer 5)Patients with histories of treatment using drugs targeting EGFR such as an anti-EGFR antibody or Regorafenib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall percent agreement (OPA) of both KRAS and NRAS gene exon 2, 3 and 4 mutations between Plasma RAS testing and Reference method | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Positive percent agreement (PPA) and negative percent agreement (NPA) between Plasma RAS testing and Reference method ?Positive predictive value (PPV) and negative predictive value (NPV) of the Plasma RAS testing versus Reference method ?Codon-based consistency of Plasma RAS testing results with those obtained using the and Reference method in patients identified with RAS mutation | — |
Countries
Japan
Outcome results
None listed