Colon Cancer, Liver Tumors
Conditions
Keywords
Tissue samples, 17-594
Brief summary
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.
Interventions
OTHERblood draws
Patients will have 10 mL of peripheral venous blood drawn immediately prior to surgery, in the post anesthesia care unit (PACU), and at the first postoperative clinic visit for a total of 30 mL.
PROCEDUREcolectomy or hepatectomy
Three small pieces of otherwise normal-appearing liver of 0.5-1 cm3 collected intraoperatively from patients in all four groups (including Group D). Because liver biopsy is less frequently performed during operations for benign colon lesions or Stage I-III colon cancers, this single aspect of the protocol can be made optional at the discretion of the surgical attending or the patient, however bloods and tissue from pathology will still be collected.
DIAGNOSTIC_TESTFibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.
Sponsors
Weill Medical College of Cornell University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 surgeons 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful isolation of exosomes | 1 year | defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval. |
Countries
United States
Outcome results
None listed