Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:

1. Male or female patients (≥18 years of age at the time of consent);
2. Stage IV colon or rectal adenocarcinoma with liver-restricted metastasis(es) for whom partial hepatectomy with curative intent is planned;
3. Instead of, or in addition to, partial hepatectomy, liver metastases may be ablated by needle radio frequency or microwave; in case of a solitary liver metastasis, three core-needle biopsies are provided for research at time of the procedure and prior to tissue destruction;
4. Patients may undergo planned two-stage partial hepatectomies;
5. Patients may have at baseline lung micro nodules or intra-abdominal enlarged nodes or nodules of unknown nature, not considered as extra-hepatic metastases in the opinion of the investigator;
6. Patients who are scheduled to receive FOLFOX-based pre-hepatectomy may receive any additional combined agents, such as and not limited to Irinotecan, anti-EGFR, and anti-VEGF drugs;
7. Patients are willing and able to provide serial blood samples, tumor and adjacent tissues, and stool samples for research;
8. The timing and specific treatments of the primary colon or rectal tumor is per SOC, at the discretion of the treating physician, including the use of pre-operative radiotherapy for rectal cancer;
9. Patients may receive post-operative adjuvant chemotherapy per SOC, at the discretion of the treating physician;
10. Patients must consent to the Exactis Personalized my Treatment registry.

Exclusion Criteria:

1. Pregnant or breastfeeding patients,
2. Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
3. Presence of concurrent other cancer(s).