A Study of Imaging, Blood, and Tissue Samples to Guide Treatment of Colon Cancer and Related Liver Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| presumptive Stage II or III colon cancer
|
Other: blood draws
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.
Procedure: colectomy or hepatectomy
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.
Diagnostic Test: Fibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.
|
| Stage IV colon cancer with resectable hepatic metastases
|
Other: blood draws
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.
Procedure: colectomy or hepatectomy
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.
Diagnostic Test: Fibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.
|
| Stage IV colon cancer with unresectable hepatic metastases
|
Other: blood draws
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.
Procedure: colectomy or hepatectomy
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.
Diagnostic Test: Fibroscan test
This may be done either at a preoperative clinic setting or immediately prior to surgery.
|
| Stage I colon cancer, pre-neoplastic or benign colon lesions
|
Other: blood draws
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.
Procedure: colectomy or hepatectomy
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memoral Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 3 | Memoral Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 4 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Michael D'Angelica, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17-594