Lung Cancer Detection by Measuring Monocyte Activity (EDLC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Blood test

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 Type: Interventional
• Enrollment (Anticipated): 950
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34362
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Subject signed the informed consent.
2. Subject is between 18 to 90 years old.
3. Lung cancer diagnosis before any treatment

Exclusion Criteria

1. Lung cancer patients
2. Subject has been previously treated for any type of malignant or benign tumor (for example: colon or uterus polyps removal).
3. Subject has active infection or inflammation determined clinically at screening.
4. Subject is currently treated with concomitant medication related directly or can affect the immune system.
5. Subject lactating or undergoing fertility treatment.
6. Subject has impaired judgment.
7. Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease.
8. Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation.
9. Known hypersensitivity and/or allergy
10. Drug or alcohol abuse (by history).
11. Subject is participating in any other clinical trial, drug or device study within 30 days prior sample collection

12. Relatives of the study investigators or employees of the study investigators are not allowed to participate in the study

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: lung cancer diagnosis; 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.	Other: Blood test; a blood test will be taken from each patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer	1 year

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Collaborators: Tel Aviv University
• Investigators: Principal Investigator: Yochai Adir, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 16, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): March 18, 2014
• Last Update Submitted That Met QC Criteria: March 16, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CMC-13-0105-CTIL