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

Inclusion Criteria:

Subject is/has:

1. 18 years of age or older.

2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous,sarcomatous,or neuroendocrine features are not eligible).

3. Post complete surgical resection of CRC, with last surgery occurring within 180 daysprior to enrollment are eligible if all of the following conditions are met:

4. in the opinion of the surgeon, all grossly visible tumor was completelyresected ("curative resection") and

5. histologic evaluation by the pathologist confirms the margins of the resectedspecimens are not involved by malignant cells. i. 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 havehad all or a portion of the adjacent structure removed en bloc with the primarytumor and local radiation therapy will not be utilized.

6. Pathologic Stage II or III CRC.

7. ECOG performance status ≤ 2 (0, 1 or 2).

8. Able to understand and provide written informed consent.

9. Willing and able to comply with the study requirements, which includes thecollection of approximately 35mL of blood for each research blood draw.

Exclusion Criteria:

Subject is/has:

1. Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapyacceptable).

2. Known pregnancy or breastfeeding at time of enrollment.

3. Prior history of any invasive cancer (including CRC) within the past 3 years priorto informed consent, with the exception of non-melanoma skin cancer. Patients with aprior history of noninvasive (in situ) carcinomas may participate after definitivetreatment.

4. Prior transplant history:

5. Prior allogeneic hematopoietic stem cell transplant at any time.

6. Prior solid organ transplant within the last 2 years prior to enrollment.

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