High Definition Single Cell Analysis in Colorectal Cancer

PRIMARY OBJECTIVES:

I. To determine the level of correlation between solid tumor touch preparations and liquid
biopsies (circulating tumor cells [CTCs]) from patients with surgically resected colorectal
cancer (CRC) metastases to the liver using single-cell high-content analysis, including gene
copy number variation (CNV) and to establish one or more bio-signatures that represent the
liquid and solid biopsy correlation for each patient and for the patient population.

SECONDARY OBJECTIVES:

I. To demonstrate the technical validity and reproducibility of the bio-signatures by
comparing the two pre-resection liquid biopsy samples drawn one week prior to and on the day
of surgery.

TERTIARY OBJECTIVES:

I. Compare biosignatures between pre-surgical and post-surgical blood samples. II. Compare
biosignatures between resected metastatic liver tumor tissue, primary colon tumor tissue (if
available), and pre-surgical blood samples.

III. Compare biosignatures between blood samples prior to resection with those obtained after
resection and at the time of recurrence.

OUTLINE:

Patients undergo blood collection 1 week prior surgery, before and after surgery on the same
day, and 1 week and 3 months after surgery. Patients also undergo tissue collection during
the surgery. Blood and tissue samples are processed for high definition single cell analysis
including whole-genome CNV profiles, protein expression, and cell morphology.

After completion of study, patients are followed up for up to 2 years.

Inclusion Criteria:

- Able to provide informed consent

- Metastatic colorectal adenocarcinoma to the liver (hepatic mCRC)

- Synchronous or metachronous

- Solitary or multifocal

- Concurrent abdominal lymph node metastasis is allowable

- Hepatic mCRC deemed surgically resectable by the study team with plans to undergo
surgery

- Has not received any systemic chemotherapy for at least 21 days prior to scheduled
hepatic resection

Exclusion Criteria:

- Non-adenocarcinoma metastatic colorectal cancer (e.g. neuroendocrine carcinoma);
mucinous component is permitted

- Metastatic CRC that involves organ(s)/tissue(s) other than abdominal lymph nodes
and/or liver

- Has received any systemic chemotherapy within 21 days prior to scheduled hepatic
resection