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Open Access 01-12-2023 | Lung Cancer | Research

A novel, accurate, and non-invasive liquid biopsy test to measure cellular immune responses as a tool to diagnose early-stage lung cancer: a clinical trials study

Authors: Shafrira Shai, Fernando Patolsky, Hagai Drori, Eyal J. Scheinman, Eyal Davidovits, Giora Davidovits, Shoval Tirman, Nadir Arber, Amit Katz, Yochai Adir

Published in: Respiratory Research | Issue 1/2023

Abstract

Introduction

Lung cancer remains the leading cause of death from cancer, worldwide. Developing early detection diagnostic methods, especially non-invasive methods, is a critical component to raising the overall survival rate and prognosis for lung cancer. The purpose of this study is to evaluate two protocols of a novel in vitro cellular immune response test to detect lung cancer. The test specifically quantifies the glycolysis metabolism pathway, which is a biomarker for the activation level of immune cells. It summarizes the results of two clinical trials, where each deploys a different protocol's version of this test for the detection of lung cancer. In the later clinical trial, an improved test protocol is applied.

Method

The test platform is based on changes in the metabolic pathways of the immune cells following their activation by antigenic stimuli associated with Lung cancer. Peripheral Blood Mononuclear Cells are loaded on a multiwell plate together with various lung tumor associated antigens and a fluorescent probe that exhibits a pH-dependent absorption shift. The acidification process in the extracellular fluid is monitored by a commercial fluorescence plate reader device in continuous reading for 3 h at 37 °C to document the fluorescent signal received from each well.

Results

In the later clinical trial, an improved test protocol was applied and resulted in increased test accuracy. Specificity of the test increased to 94.0% and test sensitivity increased to 97.3% in lung cancer stage I, by using the improved protocol.

Conclusion

The improved protocol of the novel cellular immune metabolic response based test detects stage I and stage II of lung cancer with high specificity and sensitivity, with low material costs and fast results.

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Title: A novel, accurate, and non-invasive liquid biopsy test to measure cellular immune responses as a tool to diagnose early-stage lung cancer: a clinical trials study
Authors: Shafrira Shai
Fernando Patolsky
Hagai Drori
Eyal J. Scheinman
Eyal Davidovits
Giora Davidovits
Shoval Tirman
Nadir Arber
Amit Katz
Yochai Adir
Publication date: 01-12-2023
Publisher: BioMed Central
Keywords: Lung Cancer
Lung Cancer
Lung Cancer
Biomarkers
Published in: Respiratory Research / Issue 1/2023
Electronic ISSN: 1465-993X
DOI: https://doi.org/10.1186/s12931-023-02358-w

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Abstract

Introduction

Method

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