Immunologic Signatures Following Surgery for Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03001518|
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : June 13, 2019
|Condition or disease|
|Pancreatic Cancer Surgery|
Subjects will have blood draws at the following timepoints: Pre-op, 1-2 days post-op, 3-5 days post-op, and 1-4 months post-op. At each timepoint, three 8.5mL ACD (yellow top) vacutainer tubes will be drawn by the Biobank and Translational Research Core (BRTC), study personnel, or hospital phlebotomists. The blood will be processed for PBMC isolation by BRTC for Dr. Weinhold's laboratory and will be viable within 8 hours of draw. These timepoints for blood draws are at the same time as usual operative care and will not require additional visits on the part of the subject.
For this study we will extensively utilize several polychromatic flow cytometry (PFC) platforms to follow activation, maturation, exhaustion, and proliferation patterns within CD4+ and CD8+ subsets of T-cells. We will also utilize an intracellular cytokine staining (ICS) platform in efforts to detect anti-tumor associated antigen (TAA) responses by CD4+ and CD8+ T cells from peripheral blood mononuclear cells (PBMC) as well as lymphocytes infiltrating the patient's tumor. These assays are designed to measure antigen-driven intracellular production of IFN-γ, TNF-α, and IL-2, as well as the degranulation marker CD107. This strategy enables us to not only document individual cytokine responses, but to also assess (through Boolean gating) changes in relative polyfunctionality of the responses.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Immunologic Signatures Following Surgery for Pancreatic Cancer|
|Actual Study Start Date :||May 4, 2017|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||April 2027|
No intervention. Patients who undergo surgical resection of their pancreatic cancer.
- immune response [ Time Frame: preoperatively to 3 months postoperatively ]proliferation of immune cells in peripheral plasma
- 90-day mortality [ Time Frame: 90 days ]death by 90 days
- surgical-site infection (SSI) [ Time Frame: 90 days ]occurrence of superficial or deep infection of incision(s), by erythema/warmth/pain/swelling, need for antibiotics, positive wound cultures, purulent drainage/abscess, need to open skin incision, fascial dehiscence, etc. or documentation in the record of SSI. Organ/space infection indicated by abscess, anastomotic dehiscence, positive culture, etc. or documentation in the record of same.
- pancreatic leak by qualitative appearance or amylase level [ Time Frame: 90 days ]Drain output or CT-guided drainage consistent with pancreatic fluid in appearance and/or amylase level, or documentation in record of same.
- operative time [ Time Frame: 1 day ]time from start to end of operation
- use of neoadjuvant therapy [ Time Frame: 1 day ]used = 1
- use of adjuvant therapy [ Time Frame: 90 days ]used = 1
- CA 19-9 level [ Time Frame: 90 days ]result
- return to operating room [ Time Frame: 90 days ]Reoperation for exploration or repair of complication of primary procedure. Does not include wound debridement, placement of inferior vena cava filter, interventional radiology procedures, or other procedures unrelated to the initial procedure.
- Non-SSI infection [ Time Frame: 90 days ]Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia.
- margin status [ Time Frame: 1 week ]clean or unclean
- intraoperative transfusion [ Time Frame: 1 day ]used = 1
- lymph node status [ Time Frame: 1 week ]positive or negative
- overall survival [ Time Frame: 5 years ]number of months alive
- disease-free survival [ Time Frame: 5 years ]number of months without disease
Biospecimen Retention: Samples With DNA
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): NCT03001518
|Contact: Diana Stephensonfirstname.lastname@example.org|
|Contact: Stacy Murrayemail@example.com|
|United States, North Carolina|
|Duke University Health System||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Diana Stephenson 919-613-5798 firstname.lastname@example.org|
|Principal Investigator:||Sabino Zani, MD||Duke University Health System|