First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer

Prior treatment

• Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
• Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
• Prior transplant history:
  • Prior allogeneic hematopoietic stem cell transplant at any time.
  • Prior solid organ transplant within the last 2 years prior to enrollment.

Other illness

• Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

Other

• Subject is/has:
• Known pregnancy or breastfeeding at time of enrollment.

• Subject is/has:
• 18 years of age or older.
• Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible).
• Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:
  • in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
  • histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.
  • Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension form the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
• Pathologic Stage II or III CRC.
• ECOG performance status ≤ 2 (0, 1 or 2).
• Able to understand and provide written informed consent.
• Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.