Evaluation of PD1 / PDL1 Expression on Blood Cells & Tumor Tissue, Their Role as a Prognostic Target in NSCLC Patients

Instituto Nacional de Cancerologia de Mexico150 enrolled

Overview

Several reports have examined Programmed Death 1 (PD-1) expression on tumor-infiltrating T-cells, and its correlation with prognosis has been discussed. However, Programmed Death 1 (PD1)/Programmed Death Ligand 1 (PDL1) expression on the peripheral blood T-cells of cancer patients, particularly in those with lung cancer, has not been sufficiently studied. The purpose of this study is evaluate the expression of PD1 and PDL1 in subpopulations of peripheral blood and tumor cells patients with lung cancer non-small cell (NSCLC), associating with clinicopathological features of the patients studied.

This is a prospective cohort study including patients with NSCLC stages IIIA, IIIB and IV lung cancer clinic of the National Cancer Institute (INCAN) Clinical samples. Prior and informed consent before receiving any treatment, sample be obtained 15 ml peripheral blood of each subject included in the study (patients and controls). mononuclear peripheral blood cells (PBMC) from different groups of subjects separated by centrifugation gradient (Polymorphprep, Accurate Chemical) are used. The cells are resuspended in dimethylsulfoxide (DMSO) and 10% fetal bovine serum (FBS) to 90% at a concentration of 1 million cells per ml and kept in liquid nitrogen until use. Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti- cluster of differentiation (CD) 3, anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20. Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in \<5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Non-Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria patient : 1. Patients who have understood and signed the informed consent. 2. Diagnosis of lung cancer, histologically or cytologically documented (stage IIIA / B or IV) non-small cell adenocarcinoma, which had not received radiotherapy and / or chemotherapy prior to the first sample. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and evidence of measurable disease. Exclusion Criteria patient: 1. Subjects with Non-small cell lung cancer with a different histological type to adenocarcinoma. 2. Subjects with acute inflammation and uncontrolled infections. Inclusion Criteria healthy subjects : 1. Informed consent in writing (signed) to participate in the study. 2. No diagnosis of oncological disease. 3. Subjects without symptoms of any respiratory illness in the two weeks prior to sampling. Exclusion criteria healthy volunteers. 1\. Any unstable systemic disease (including active or metabolic infection, congestive heart failure, liver disease, kidney).

Outcomes

Primary Outcomes

Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC)

Immunolocalization of PD-1, PD-L1 in lung tumor tissue of patients with NSCLC. Immunohistochemical staining (IHC). Lung biopsy is obtained paraffin blocks, and are processed by IHC technique for antitumor expression of PD1 / PDL1.V PD-L1 immunostaining was classified into two groups according to intensity and extent: (a) negative, when no staining or positive staining was detected in \<5% of the cells; and (b) positive, when membranous staining was present in P5% of the cells.

Time frame: Baseline evaluation

Secondary Outcomes

Evaluation of PD-1, PD-L1 by flow cytometry.

Evaluation of PD-1, PD-L1 by flow cytometry. The following monoclonal antibodies directed against cell surface antigens of human are used: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 3 (CD3), anti-CD4, anti-CD8, anti-CD14, anti-CD16, anti-CD56, anti-CD19, anti-CD20.