Circulating Tumor Cells in Operative Blood

NCT02150746 | Completed

• 1 other identifier: 2014-00271
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

Pancreatic ductal adenocarcinoma; Pancreatic cancer; PDAC; Circulating tumor cells

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with isolated circulating tumor cells

  2 days

• Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells

  6 months

Study Arms (1)

Pancreatic Cancer CTC

Peripheral/Central Venous Blood Draw Peritoneal Wash

Procedure: Peripheral/Central Venous Blood Draw; Procedure: Peritoneal Wash

Interventions

Peripheral/Central Venous Blood Draw PROCEDURE

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.

Pancreatic Cancer CTC

Peritoneal Wash PROCEDURE

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.

Pancreatic Cancer CTC

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18-85 years with a confirmed tissue diagnosis of pancreatic ductal adenocarcinoma who are scheduled to undergo curative surgery.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Shands Hospital at the University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (6)

• 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.

  PMID: 19194760 BACKGROUND

• 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.

  PMID: 23973112 BACKGROUND

• 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.

  PMID: 18471707 BACKGROUND

• 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.

  PMID: 22481921 BACKGROUND

• 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.

  PMID: 19638909 BACKGROUND

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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood Buffy coat isolated from collected whole blood

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal; Pancreatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan M Thomas, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: February 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)