Circulating Tumor Cells in Operative Blood
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | February 2016 |
Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence
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.
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.
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.
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.
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
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