Clinical Trial: Circulating Tumor Cells in Operative Blood
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence
Brief Summary: It is hypothesized that circulating tumor cells (CTCs) from pancreatic adenocarcinoma are released into the peritoneal cavity through blood lost during the surgical resection of these tumors resulting in peritoneal recurrence despite appropriate surgical resection. Targeting the mechanisms responsible for CTC adhesion to the peritoneum may result in inhibition of implantation and growth, thus preventing this mode of pancreatic cancer recurrence postoperatively.
Detailed Summary:
Research Plan:
Intraoperative Subjects with Pancreatic Ductal Adenocarcinoma (PDAC) who have been consented and enrolled into the study will be taken to the operating room (OR) for their previously planned pancreatectomy procedure. After general anesthesia is induced, using universal precautions, blood sample (10ml) will be collected into a heparin tube for identification of circulating tumor cells (CTCs) and serve as one of two controls designed to assess background CTC counts. Once the participant has undergone surgical exploration as planned and has been deemed a candidate for resection, normal saline will be used to wash the abdominal cavity and collected in a suction canister by the attending surgeon. Abdominal washings are a normal part of the operative procedure, typically performed at the end of the operation to wash blood out of the abdominal cavity and is performed with variable amounts depending on the surgeon's discretion. For purposes of a control for the study, this wash step will be moved to the beginning of the operation. Additional washes/irrigations may be necessary at the end of the case at the surgeon's discretion. Cells collected in this fluid will be centrifuged and collected in the lab for determination of the presence of malignant cells. This will serve as the second of two controls. As the pancreatectomy procedure proceeds, subject blood will be lost as a normal consequence of the procedure and suctioned from the operative field into a new container containing heparin chilled on ice to preserve cell viability. This blood is normally discarded at the end of the case but a portion of the blood will be collected and utilized for downstream lab experiments to detect CTCs.
Laboratory/Post-Processing Blood collected in the operating room as described above will be immediately brought to the laboratory an
Sponsor: University of Florida
Current Primary Outcome:
- Percentage of patients with isolated circulating tumor cells [ Time Frame: 2 days ]
- Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Florida
Dates:
Date Received: May 27, 2014
Date Started: February 2015
Date Completion:
Last Updated: February 22, 2016
Last Verified: February 2016
