Table 1.
Category | Inclusion criteria | Exclusion criteria |
Demographics | Patients must be 18 years of age or older, be able to read, understand and provide written informed consent, and be willing and able to comply with study requirements | Patients that are pregnant or breast feeding |
Clinical presentation | Patients must be pathologically diagnosed with stage I to III CRC or stage IV with oligometastatic disease; eligible for surgical resection or ablation; have an ECOG performance status of ≤2 | Patients with history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer; has a known rare inherited genetic condition, with the exception of lynch syndrome |
Medical history | Patients must be clinically eligible for postoperative systemic therapy (adjuvant chemotherapy or immunotherapy); venipuncture for research blood draws | Patients who have already initiated postoperative systemic therapy; patients with a history of bone marrow or organ transplant; medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder. Patients with neuropathy >grade 2; patients that have serious medical conditions that may adversely affect their ability to participate in this study |
Provider-based criteria | Patients must be selected by their provider to receive the bespoke ctDNA test, according to the current evidence-informed schedule, as part of their routine practice |
CRC, colorectal cancer; ctDNA, circulating tumour DNA; ECOG, Eastern Cooperative Oncology Group.