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

Study Overview
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Brief Summary
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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.

Official Title
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Development of Novel Imaging and Laboratory Biomarkers to Monitor the Liver Pre-metastatic Niche and Guide Treatment of Colon Cancer: A Pilot Study

Conditions
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Colon Cancer, Liver Tumors

Intervention / Treatment
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* Other: blood draws
* Procedure: colectomy or hepatectomy
* Diagnostic Test: Fibroscan test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| presumptive Stage II or III colon cancer<br> | Other: blood draws<br>* 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.<br>Procedure: colectomy or hepatectomy<br>* 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.<br>Diagnostic Test: Fibroscan test<br>* This may be done either at a preoperative clinic setting or immediately prior to surgery.<br>|
| Stage IV colon cancer with resectable hepatic metastases<br> | Other: blood draws<br>* 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.<br>Procedure: colectomy or hepatectomy<br>* 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.<br>Diagnostic Test: Fibroscan test<br>* This may be done either at a preoperative clinic setting or immediately prior to surgery.<br>|
| Stage IV colon cancer with unresectable hepatic metastases<br> | Other: blood draws<br>* 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.<br>Procedure: colectomy or hepatectomy<br>* 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.<br>Diagnostic Test: Fibroscan test<br>* This may be done either at a preoperative clinic setting or immediately prior to surgery.<br>|
| Stage I colon cancer, pre-neoplastic or benign colon lesions<br> | Other: blood draws<br>* 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.<br>Procedure: colectomy or hepatectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful isolation of exosomes | defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tissue samples, 17-594