Circulating Tumor Cells in Operative Blood
Condition: Carcinoma, Pancreatic Ductal
MeSH terms: Neoplastic Cells, Circulating; Carcinoma, Pancreatic Ductal
Study type: Observational

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 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.
    

Intervention name(s): Peripheral/Central Venous Blood Draw; Peritoneal Wash
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Observational model: Case-Only
Time perspective: Prospective
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.
      
Biospecimen description: 
      Whole blood Buffy coat isolated from collected whole blood
    
Keywords: Pancreatic ductal adenocarcinoma; Pancreatic cancer; PDAC; Circulating tumor cells