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

Active, not recruiting

• Conditions: Colon Cancer; Liver Tumors

• Registration Number: NCT03432806
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States