Skip to main content
OpenTrials
Completed

NCT Number: NCT03001518

Immunologic Signatures Following Surgery for Pancreatic Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. immune response

    Time frame: preoperatively to 3 months postoperatively

    proliferation of immune cells in peripheral plasma

Secondary outcomes

  1. 90-day mortality

    Time frame: 90 days

    death by 90 days

  2. 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.

  3. 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.

  4. operative time

    Time frame: 1 day

    time from start to end of operation

  5. use of neoadjuvant therapy

    Time frame: 1 day

    used = 1

  6. use of adjuvant therapy

    Time frame: 90 days

    used = 1

  7. CA 19-9 level

    Time frame: 90 days

    result

  8. 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.

  9. Non-SSI infection

    Time frame: 90 days

    Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia.

  10. margin status

    Time frame: 1 week

    clean or unclean

  11. intraoperative transfusion

    Time frame: 1 day

    used = 1

  12. lymph node status

    Time frame: 1 week

    positive or negative

  13. overall survival

    Time frame: 5 years

    number of months alive

  14. disease-free survival

    Time frame: 5 years

    number of months without disease

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2023
First posted
Dec 23, 2016
Registry last updated
Jun 28, 2023

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.