A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Live… (NCT03432806) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
United States51 participantsStarted 2017-11-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 o…