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Active, Not Recruiting

NCT Number: NCT03432806

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draws

Other

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.

colectomy or hepatectomy

Procedure

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.

Fibroscan test

Diagnostic Test

This may be done either at a preoperative clinic setting or immediately prior to surgery.

Primary outcomes

  1. successful isolation of exosomes

    Time frame: 1 year

    defined as isolation of at least 5μg of exosomal protein and reported as a binomial proportion with a 95% confidence interval.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2018
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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