Lung Cancer Detection by Measuring Monocyte Activity

NCT02090166 | Unknown

• 1 other identifier: CMC-13-0105-CTIL
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer

  1 year

Study Arms (1)

lung cancer diagnosis

OTHER

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

Interventions

Blood test OTHER

a blood test will be taken from each patient

lung cancer diagnosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Lung cancer patients
• Subject has been previously treated for any type of malignant or benign tumor (for example: colon or uterus polyps removal).
• Subject has active infection or inflammation determined clinically at screening.
• Subject is currently treated with concomitant medication related directly or can affect the immune system.
• Subject lactating or undergoing fertility treatment.
• Subject has impaired judgment.
• Known positive HIV, hepatitis B, or hepatitis C, autoimmune disease.
• Known history of a significant medical disorder, which in the investigators' judgment contraindicates the patient's participation.
• Known hypersensitivity and/or allergy
• Drug or alcohol abuse (by history).
• Subject is participating in any other clinical trial, drug or device study within 30 days prior sample collection
• Relatives of the study investigators or employees of the study investigators are not allowed to participate in the study

Sponsors & Collaborators

• Carmel Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Carmel Medical Center

Haifa, 34362, Israel

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Yochai Adir, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yochai Adir, MD

CONTACT

+972-4-8250517; yochaiad@clalit.org.il

Amer Ubaid

CONTACT

+972-4-8250515; AmerUb@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 18, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

IL (1)