Circulating Tumor Cells in Operative Blood

Carcinoma, Pancreatic Ductal Clinical Trial

Official title:

Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02150746
• Other study ID #: 2014-00271
• Status: Completed
• Phase: N/A
• First received: May 27, 2014
• Last updated: February 22, 2016
• Start date: February 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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 and centrifuged to separate out the plasma, buffy coat, and erythrocytes. The buffy coat, which contains the CTCs, white blood cells, and platelets, is removed and added to the commercially available cocktail per the kit protocol. Ficoll enrichment and separation of the CTCs will then be performed. The isolated CTCs will then be used for further downstream characterization and experimentation which will include, but not limited to: identification of CTC number, growth of CTCs in vitro and in vivo, and identification/characterization of CTC adhesion molecules which allow binding to human peritoneum. Any unused blood or component of blood not utilized in the experiment will be assigned a unique identifier and de-identified of patient for future cross-reference and stored at -80 degrees Fahrenheit at the University of Florida for potential future experiments or repeat CTC isolation.

Participant Data Collection On all enrolled subjects, the following de-identified information will be collected: participant demographic data, clinical and pathologic data, and data on cancer recurrence and overall survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Confirmed tissue diagnosis of pancreatic ductal adenocarcinoma

• Scheduled to undergo pancreatectomy (open or minimally invasive) with curative intent

• Aged 18-85 years

• No race restrictions

Exclusion Criteria:

• Patients who have undergone preoperative therapy with either chemotherapy, radiation therapy, or both

• Serum CA19-9 less than 200ng/ml

• Patients with prior history of gastrointestinal malignancy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Pancreatic Ductal
• Neoplastic Cells, Circulating

Intervention

Procedure:
• Peripheral/Central Venous Blood Draw
Baseline sample of whole blood to be assessed for circulating tumor cells. Samples will be acquired via venipuncture unless a pre-existing central venous catheter is in place in which case the sample will be drawn from this.
• Peritoneal Wash
Prior to the start of the surgical resection, irrigation of the abdominal cavity will be performed and collected to determine baseline pancreatic cancer cells that may be present in the abdominal cavity.

Locations

Country	Name	City	State
United States	Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013

Katz MH, Pisters PW, Evans DB, Sun CC, Lee JE, Fleming JB, Vauthey JN, Abdalla EK, Crane CH, Wolff RA, Varadhachary GR, Hwang RF. Borderline resectable pancreatic cancer: the importance of this emerging stage of disease. J Am Coll Surg. 2008 May;206(5):833-46; discussion 846-8. doi: 10.1016/j.jamcollsurg.2007.12.020. Epub 2008 Mar 17. — View Citation

Katz MH, Wang H, Fleming JB, Sun CC, Hwang RF, Wolff RA, Varadhachary G, Abbruzzese JL, Crane CH, Krishnan S, Vauthey JN, Abdalla EK, Lee JE, Pisters PW, Evans DB. Long-term survival after multidisciplinary management of resected pancreatic adenocarcinoma. Ann Surg Oncol. 2009 Apr;16(4):836-47. doi: 10.1245/s10434-008-0295-2. Epub 2009 Feb 5. — View Citation

Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Kuhara H, Eto K, Baba H. A proposal of a practical and optimal prophylactic strategy for peritoneal recurrence. J Oncol. 2012;2012:340380. doi: 10.1155/2012/340380. Epub 2012 Feb 8. — View Citation

Kuramoto M, Shimada S, Ikeshima S, Matsuo A, Yagi Y, Matsuda M, Yonemura Y, Baba H. Extensive intraoperative peritoneal lavage as a standard prophylactic strategy for peritoneal recurrence in patients with gastric carcinoma. Ann Surg. 2009 Aug;250(2):242-6. doi: 10.1097/SLA.0b013e3181b0c80e. — View Citation

Sugiura T, Uesaka K, Mihara K, Sasaki K, Kanemoto H, Mizuno T, Okamura Y. Margin status, recurrence pattern, and prognosis after resection of pancreatic cancer. Surgery. 2013 Nov;154(5):1078-86. doi: 10.1016/j.surg.2013.04.015. Epub 2013 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with isolated circulating tumor cells		2 days	No
Primary	Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells		6 months	No