Carcinoma, Pancreatic DuctalNCT02150746
Circulating Tumor Cells in Operative Blood
An observational study of Carcinoma, Pancreatic Ductal, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- Peripheral/Central Venous Blood Draw and Peritoneal Wash
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands Hospital at the University of Florida
Gainesville, Florida, 32608
About this study
Official title: 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.
Read the 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.
- Conditions
- Carcinoma, Pancreatic Ductal
- Being tested
- Peripheral/Central Venous Blood Draw, Peritoneal Wash
- Keywords
- Pancreatic ductal adenocarcinoma, Pancreatic cancer, PDAC, Circulating tumor cells
- Medical subject headings
- Carcinoma, Pancreatic Ductal, Pancreatic Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral/Central Venous Blood DrawProcedure or surgery
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 WashProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cancer CTC | Peripheral/Central Venous Blood Draw Peritoneal Wash Receives: Procedure: Peripheral/Central Venous Blood Draw; Procedure: Peritoneal Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with isolated circulating tumor cells
Measured: 2 days
Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan M Thomas, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150746
- Sponsor's protocol ID
- 2014-00271
- Other IDs
- 2014
- Status last verified
- Feb 2016
- First submitted
- 27 May 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19194760Sugiura 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.
PubMed 23973112Katz 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.
PubMed 18471707Kuramoto 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.
PubMed 22481921Kuramoto 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.
PubMed 19638909Cancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells Shed in Operative Blood During Pancreatectomy for Pancreatic Cancer is Responsible for Peritoneal Recurrence
- ClinicalTrials.gov ID
- NCT02150746
- Acronym / sponsor ID
- 2014-00271
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- Pancreatic ductal adenocarcinoma, Pancreatic cancer, PDAC, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cancer CTC | – | Procedure: Peripheral/Central Venous Blood Draw, Procedure: Peritoneal WashPeripheral/Central Venous Blood Draw Peritoneal Wash |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral/Central Venous Blood DrawBaseline 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 or surgery | Pancreatic Cancer CTC |
| Peritoneal WashPrior 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. | Procedure or surgery | Pancreatic Cancer CTC |
Primary outcome
Percentage of patients with isolated circulating tumor cells
Time frame: 2 days
Percentage of patients with successful in vivo animal engraftment of isolated circulating tumor cells
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Background: PubMed 19194760Katz 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.
- Background: PubMed 23973112Sugiura 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.
- Background: PubMed 18471707Katz 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.
- Background: PubMed 22481921Kuramoto 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.
- Background: PubMed 19638909Kuramoto 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.
- BackgroundCancer Facts & Figures 2013. Atlanta: American Cancer Society; 2013
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan M Thomas, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Pancreatic Ductal, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with isolated circulating tumor cells (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02150746, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.