A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
Active, not recruiting
- Conditions
- Colon CancerLiver Tumors
- Interventions
- Other: blood drawsProcedure: colectomy or hepatectomyDiagnostic Test: Fibroscan test
- 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
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
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stage IV colon cancer with resectable hepatic metastases colectomy or hepatectomy - Stage I colon cancer, pre-neoplastic or benign colon lesions blood draws - presumptive Stage II or III colon cancer blood draws - presumptive Stage II or III colon cancer Fibroscan test - Stage IV colon cancer with resectable hepatic metastases Fibroscan test - Stage IV colon cancer with resectable hepatic metastases blood draws - Stage IV colon cancer with unresectable hepatic metastases Fibroscan test - presumptive Stage II or III colon cancer colectomy or hepatectomy - Stage IV colon cancer with unresectable hepatic metastases blood draws - Stage I colon cancer, pre-neoplastic or benign colon lesions colectomy or hepatectomy - Stage IV colon cancer with unresectable hepatic metastases colectomy or hepatectomy -
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸Harrison, New York, United States
Memorial Sloan Kettering Basking Ridge
🇺🇸Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack
🇺🇸Commack, New York, United States