Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunologic Signatures Following Surgery for Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Pancreatic Cancer Surgery

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Surgery
No intervention. Patients who undergo surgical resection of their pancreatic cancer.



Primary Outcome Measures :
  1. immune response [ Time Frame: preoperatively to 3 months postoperatively ]
    proliferation of immune cells in peripheral plasma


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Plasma from 4 blood draws


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pancreatic ductal adenocarcinoma who undergo surgical resection of the cancer, with or without irreversible electroporation.
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


Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Diana Stephenson 919-613-5798 diana.stephenson@duke.edu
Contact: Stacy Murray 919-684-7983 stacy.murray@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27710
Contact: Diana Stephenson    919-613-5798    diana.stephenson@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Sabino Zani, MD Duke University Health System

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03001518     History of Changes
Other Study ID Numbers: Pro00077435
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases