Lung Cancer Detection by Measuring Monocyte Activity — EDLC  

Lung Cancer Clinical Trial

Official title: Lung Cancer Detection and Staging by Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC)

Status Not yet recruiting

Clinical Trial Summary

Purpose: To evaluate the performance of Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung cancer.

The study population will include a total of 950 participants, patients with lung cancer before any treatment, and healthy and COPD patients as a control group.

Clinical Trial Description

The purpose of the study is to evaluate the performance of Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC) analysis method in identifying lung cancer.

The analysis method described in this protocol is a novel simple plausible immunological approach which is non-invasive, high throughput, real-time quantitative monitoring of metabolic activity (MA) profiles of fresh Peripheral Blood Mononuclear Cells (PBMC) in response to various reagents at different concentrations.

Study Design Prospective, three groups, open, comparative, controlled study. No. of Sites One Study Population Man and Women aged 18 - 90 years old. No. of Subjects A total of 950 completed, evaluated subjects will be enrolled in this study.

The groups sample size is as follows:

Group 1 - 75 subjects Group 2 - 75 subjects Group 3 - 150 subjects Group 4 - 650 subjects

Primary End Point 1. Positive and negative diagnosis (scored 0/1 dichotomously) in accordance with clinical data collected

Data Analysis and Statistics Multiple MA profiles including a huge number of MA rates values are obtained for each subject. In order to develop a dynamic clinical analysis that is updated with every new subject, and to extract patterns from this large data base, The research team designed computer programming using Data Mining tools, which combine methods from statistics and artificial intelligence with database management.

Blood test will be perform from each subject. The blood sample in eah subject will be compare to his status : healthy non smoker, healthy smoker, COPD or diagnosed with lung cancer. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT02090166
• Study type: Interventional
• Source: Carmel Medical Center
• Contact: Yochai Adir, MD
• Phone: +972-4-8250517
• Email: yochaiad@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2014
• Completion date: January 2021