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



Status:Recruiting
Conditions:Colorectal Cancer, Liver Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/20/2018
Start Date:November 28, 2017
End Date:November 2019
Contact:Michael D'Angelica, MD
Email:dangelim@mskcc.org
Phone:212-639-3226

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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

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.


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
We found this trial at
4
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 212-639-3226
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Commack, New York 11725
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Harrison, New York
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