A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Colon Cancer; Liver Tumors

Treatments: Diagnostic Test: Fibroscan test; Procedure: colectomy or hepatectomy; Other: blood draws

Study type: Observational

Funder types: Other

Identifiers

NCT03432806

17-594

Details and patient eligibility

About

The purpose of this study is to explore novel ways of diagnosing colon cancer and predicting its propensity to spread to other organs such as the liver.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be undergoing one of the following procedures as part of their routine care in order to meet the inclusion criteria:

  • Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP)
  • Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas)

• Open, laparoscopic, or robotic resections

• ≥18 years old

Exclusion criteria

• Extrahepatic CRC metastasis
• No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma.
• Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy.
• Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an exclusion criterion.
• History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer)
• Colon cancer with microsatellite instability (MSI-high) if known preoperatively
• Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC)
• Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc)
• INR >2 or known clotting factor deficiency
• Anticipated need for full anticoagulation during hospitalization
• Receipt of medications that increase significantly the risk of bleeding after liver biopsy (at the surgeon"s discretion)
• Intraoperative discovery of pathology that precludes the planned surgical resection or liver biopsy, or makes resection futile (such as peritoneal carcinomatosis or other extrahepatic metastatic disease)
• Operating surgeon deems research interventions to be more than a minimal risk for the patient

Trial design

51 participants in 4 patient groups

presumptive Stage II or III colon cancer

Treatment:

Other: blood draws

Procedure: colectomy or hepatectomy

Diagnostic Test: Fibroscan test

Stage IV colon cancer with resectable hepatic metastases

Treatment:

Other: blood draws

Procedure: colectomy or hepatectomy

Diagnostic Test: Fibroscan test

Stage IV colon cancer with unresectable hepatic metastases

Treatment:

Other: blood draws

Procedure: colectomy or hepatectomy

Diagnostic Test: Fibroscan test

Stage I colon cancer, pre-neoplastic or benign colon lesions

Treatment:

Other: blood draws

Procedure: colectomy or hepatectomy