Status:
ACTIVE_NOT_RECRUITING
A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Weill Medical College of Cornell University
Conditions:
Colon Cancer
Liver Tumors
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03432806
Start Date
November 28 2017
End Date
November 1 2026
Last Update
December 2 2025
Active Locations (4)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065