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Circulating Tumor Cells in Operative Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02150746
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Carcinoma, Pancreatic Ductal Procedure: Peripheral/Central Venous Blood Draw Procedure: Peritoneal Wash

Detailed 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.

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Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence
Study Start Date : February 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreatic Cancer CTC
Peripheral/Central Venous Blood Draw Peritoneal Wash
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.

Procedure: 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.




Primary Outcome Measures :
  1. Percentage of patients with isolated circulating tumor cells [ Time Frame: 2 days ]
  2. Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Whole blood Buffy coat isolated from collected whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150746


Locations
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United States, Florida
Shands Hospital at the University of Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Ryan M Thomas, MD University of Florida

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

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02150746    
Other Study ID Numbers: 2014-00271
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Florida:
Pancreatic ductal adenocarcinoma
Pancreatic cancer
PDAC
Circulating tumor cells
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Carcinoma, Pancreatic Ductal
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases