Immunologic Signatures Following Surgery for Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Immunologic Signatures Following Surgery for Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001518
• Other study ID #: Pro00077435
• Status: Completed
• Start date: May 4, 2017
• Est. completion date: January 6, 2023

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 6, 2023
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune response	proliferation of immune cells in peripheral plasma	preoperatively to 3 months postoperatively
Secondary	90-day mortality	death by 90 days	90 days
Secondary	surgical-site infection (SSI)	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.	90 days
Secondary	pancreatic leak by qualitative appearance or amylase level	Drain output or CT-guided drainage consistent with pancreatic fluid in appearance and/or amylase level, or documentation in record of same.	90 days
Secondary	operative time	time from start to end of operation	1 day
Secondary	use of neoadjuvant therapy	used = 1	1 day
Secondary	use of adjuvant therapy	used = 1	90 days
Secondary	CA 19-9 level	result	90 days
Secondary	return to operating room	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.	90 days
Secondary	Non-SSI infection	Any infection not covered by surgical-site infection, such as urinary tract infection or pneumonia.	90 days
Secondary	margin status	clean or unclean	1 week
Secondary	intraoperative transfusion	used = 1	1 day
Secondary	lymph node status	positive or negative	1 week
Secondary	overall survival	number of months alive	5 years
Secondary	disease-free survival	number of months without disease	5 years