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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
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date December 15, 2016
First Posted Date December 23, 2016
Last Update Posted Date June 13, 2019
Actual Study Start Date May 4, 2017
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2016)
immune response [ Time Frame: preoperatively to 3 months postoperatively ]
proliferation of immune cells in peripheral plasma
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03001518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 11, 2019)
  • 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
Original Secondary Outcome Measures
 (submitted: December 20, 2016)
  • 90-day mortality [ Time Frame: 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 ]
  • use of neoadjuvant therapy [ Time Frame: 1 day ]
  • use of adjuvant therapy [ Time Frame: 90 days ]
  • CA 19-9 level [ Time Frame: 90 days ]
  • 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 ]
  • intraoperative transfusion [ Time Frame: 1 day ]
  • lymph node status [ Time Frame: 1 week ]
  • overall survival [ Time Frame: 5 years ]
  • disease-free survival [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunologic Signatures Following Surgery for Pancreatic Cancer
Official Title Immunologic Signatures Following Surgery for Pancreatic Cancer
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma from 4 blood draws
Sampling Method Non-Probability Sample
Study Population Patients with pancreatic ductal adenocarcinoma who undergo surgical resection of the cancer, with or without irreversible electroporation.
Condition
  • Pancreatic Cancer
  • Surgery
Intervention Not Provided
Study Groups/Cohorts Surgery
No intervention. Patients who undergo surgical resection of their pancreatic cancer.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 20, 2016)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2027
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subject must be at least 18 years of age and at least the minimum age of majority according to applicable State or Country Law.
  • Subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and pancreatectomy for diagnosis of cancer
  • Subject is willing and able to undergo additional blood draws

Exclusion Criteria:

• Subject is not a suitable candidate for surgery, or surgery is unable to be completed

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diana Stephenson 919-613-5798 diana.stephenson@duke.edu
Contact: Stacy Murray 919-684-7983 stacy.murray@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03001518
Other Study ID Numbers Pro00077435
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Sabino Zani, MD Duke University Health System
PRS Account Duke University
Verification Date May 2019