A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections
|ClinicalTrials.gov Identifier: NCT01749332|
Recruitment Status : Active, not recruiting
First Posted : December 13, 2012
Last Update Posted : July 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Other: Perihepatic Phlebotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Perihepatic Phlebotomy During Hepatic Resections|
|Actual Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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|
- ctDNA differences [ Time Frame: once at the time of surgery ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|