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. 2021 Sep 24;11(9):e047831. doi: 10.1136/bmjopen-2020-047831

Table 1.

Eligibility criteria

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.