Lung Cancer Detection by Measuring Monocyte Activity

Not Applicable

• Conditions: Lung Cancer
• Interventions: Other: Blood test

• Registration Number: NCT02090166
• Lead Sponsor: Carmel Medical Center

Brief 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.

Detailed 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 Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-16
• Last Update Submitted: 2014-03-16
• Study First Posted: 2014-03-18
• Last Update Posted: 2014-03-18
• Study Start: 2014-04
• Primary Completion: 2020-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lung cancer diagnosis	Blood test	4 arms will be included in the study: The groups sample size is as follows: Group 1 - Healthy non smoker- 75 subjects Group 2 - Healthy smoker- 75 subjects Group 3 - Patients diagnosed as having COPD- 150 subjects Group 4 - Patients with diagnosis of lung cancer- 650 subjects A blood test will be taken from each patient.

Primary Outcome Measures

Name	Time	Method
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer	1 year

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel