Lung Cancer Detection by Measuring Monocyte Activity

NCT ID: NCT02090166

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 950 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2021-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Blood test

Intervention Type: OTHER

a blood test will be taken from each patient

Interventions

Blood test

a blood test will be taken from each patient

Intervention Type: OTHER

Eligibility Criteria

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yochai Adir, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

Central Contacts

Yochai Adir, MD

Role: CONTACT

yochaiad@clalit.org.il

+972-4-8250517 ext. 1

Amer Ubaid

Role: CONTACT

AmerUb@clalit.org.il

+972-4-8250515 ext. 2

Facility Contacts

Sharon Monsther

Role: primary

monshter_sharon@clalit.org.il

+972-4-8250517 ext. 2

Other Identifiers

CMC-13-0105-CTIL

Identifier Type: -

Identifier Source: org_study_id