A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections
The purpose of this study is to draw blood from vessels near the liver in patients undergoing liver surgery. This will be performed in both patients with cancer in order to learn more about circulating tumor cells, proteins and DNA mutations in the blood.
The blood in patients with colorectal cancer with liver metastases will be compared to blood taken from patients that do not have cancer that do not have cancer.
Inclusion of patients with benign pathology will allow for the establishment of "normal" values which currently do not exist. We will then study whether tumor mutations can be used to predict recurrence and survival patterns.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections|
- ctDNA differences [ Time Frame: once at the time of surgery ] [ Designated as safety issue: Yes ]to collect preliminary data on perihepatic and peripheral ctDNA differences between prehepatic and posthepatic sites in patients with and without primary colorectal cancers in place.
- collect preliminary data [ Time Frame: 1 year ] [ Designated as safety issue: No ]to correlate perihepatic and peripheral ctDNA mutation with recurrence and survival patterns. This will be performed by log-ranks tests of recurrence free survival and overall survival for each gene and possibly for the most common combinations of mutations
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Pts having liver or colon surgery
Blood will be obtained from patients at the time of laparotomy for hepatic resection and/or hepatic arterial infusion pump placement, or pancreatic head resection . Blood will be drawn from a peripheral vein or artery (when an arterial catheter is present), the portal vein, and suprahepatic IVC and given to a research assistant and placed on ice followed by immediate processing. Total amount of blood drawn will not exceed fifty milliliters (50ml).
|Other: Perihepatic Phlebotomy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749332
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michael D'Angelica, MD||Memorial Sloan Kettering Cancer Center|