Duke University Health System
Durham, North Carolina, 27710, United States
NCT Number: NCT03001518
The goal of this pilot study is to evaluate and describe the immunologic and overall outcomes of subjects who undergo routine pancreatectomy with or without irreversible electroporation (IRE) for pancreatic cancer. Immunologic markers in the blood will be measured at several time points before and after surgery to determine if surgical approach is associated with different immunologic responses. Secondary outcomes will include mortality and morbidity; operative time; blood loss and transfusion requirements; and oncologic outcomes such as: margin status, lymph node harvest, disease-free survival, and overall survival. Analysis of immune response will help the investigator determine whether to expand the pilot into a larger study.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: preoperatively to 3 months postoperatively
proliferation of immune cells in peripheral plasma
Time frame: 90 days
death by 90 days
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.
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.
Time frame: 1 day
time from start to end of operation
Time frame: 1 day
used = 1
Time frame: 90 days
used = 1
Time frame: 90 days
result
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.
Time frame: 90 days
Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia.
Time frame: 1 week
clean or unclean
Time frame: 1 day
used = 1
Time frame: 1 week
positive or negative
Time frame: 5 years
number of months alive
Time frame: 5 years
number of months without disease
Duke University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06079229
Digestive System Diseases, Digestive System Neoplasms
Lyon, France
View Trial DetailsNCT04596865
Adenocarcinoma, Ampullary Cancer
Clayton, Victoria, Australia
View Trial DetailsNCT01248663
Digestive System Diseases, Digestive System Neoplasms
Vienna, Austria
View Trial DetailsNCT04025840
Dexamethasone, Digestive System Diseases
Beijing, Beijing Municipality, China
View Trial Details