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Clinical Trials/NCT04657237
NCT04657237
Unknown
Not Applicable

Effect of Anesthesia and Surgical Stress on the Expression of Programmed Death-1 and Programmed Death-1 Ligand on T Lymphocyte After Breast Cancer Surgeries

Assiut University1 site in 1 country20 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Programmed Cell Death 1
Sponsor
Assiut University
Enrollment
20
Locations
1
Primary Endpoint
change in level of PD1 and PD1 ligand postoperatively
Last Updated
5 years ago

Overview

Brief Summary

Surgery is first-line treatment for solid tumors. However, surgical trauma-induced physiologic stress has been demonstrated to facilitate metastasis and recurrence in different types of cancer. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

Detailed Description

The cellular immune response plays a central part in postoperative clearance of tumor cells. T lymphocytes and natural killer (NK) cells are two predominant cytotoxic effector cells that are the major components of antitumor immunity. In mouse models, proliferation of T lymphocytes in response to surgical trauma is defective . Programmed death-1 (PD-1) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
November 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain managment

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients scheduled for breast cancer surgery

Exclusion Criteria

  • compromised immune function (such as infection with the human immunodeficiency virus, immunodeficiency, or treatment with corticosteroids, immunosuppressive drugs, or chemotherapy)
  • ASA \> III
  • age\> 70 years old.
  • patients refusal to the procedure.
  • Infection of the skin at or near site of needle puncture.
  • Coagulopathy .
  • Drug hypersensitivity or allergy to the studied drugs.
  • Central or peripheral neuropthy .
  • Pre-operative opoid consumption ( within 24 hours preoperative )
  • Anomalies of the vertebral column .

Outcomes

Primary Outcomes

change in level of PD1 and PD1 ligand postoperatively

Time Frame: preoerative (day-0),1st day, and 3 rd day after surgery

blood sample will be withdrawn and human peripheral blood monocyte cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately. For ex vivo experiments, PBMCs will be cultured with Iscove's modified Dulbecco's medium (IMDM) containing 10 % human serum albumin.

Secondary Outcomes

  • total request of analgesia(24 hours postoperative)

Study Sites (1)

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