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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer; Liver Tumors
• Intervention / Treatment: Other: blood draws; Procedure: colectomy or hepatectomy; Diagnostic test: Fibroscan test

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

• Study Contact: Name: Michael D'Angelica, MD; Phone Number: 212-639-3226; Email: dangelim@mskcc.org
• Study Contact Backup: Name: Martin Wieser, MD; Phone Number: 212-639-6698

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

MSK clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
presumptive Stage II or III colon cancer	Other: blood 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.; Procedure: colectomy 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 test: Fibroscan test; This may be done either at a preoperative clinic setting or immediately prior to surgery.
Stage IV colon cancer with resectable hepatic metastases	Other: blood 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.; Procedure: colectomy 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 test: Fibroscan test; This may be done either at a preoperative clinic setting or immediately prior to surgery.
Stage IV colon cancer with unresectable hepatic metastases	Other: blood 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.; Procedure: colectomy 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 test: Fibroscan test; This may be done either at a preoperative clinic setting or immediately prior to surgery.
Stage I colon cancer, pre-neoplastic or benign colon lesions	Other: blood 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.; Procedure: colectomy 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Michael D'Angelica, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Tissue samples; 17-594
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 17-594

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No