Lung CancerEDLCNCT02090166
Lung Cancer Detection by Measuring Monocyte Activity
A study testing Blood test in people with Lung Cancer, run by Carmel Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject signed the informed consent.
- Subject is between 18 to 90 years old.
- Lung cancer diagnosis before any treatment
Who cannot join
- 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.
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- 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
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Carmel Medical Center
Haifa, 34362
Sharon Monsther, +972-4-8250517 ext. 2, monshter_sharon@clalit.org.il
Michal Shteinberg, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Blood test
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
a blood test will be taken from each patient
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Yochai Adir, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090166
- Sponsor's protocol ID
- CMC-13-0105-CTIL
- Acronym
- EDLC
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Detection and Staging by Extracellular Monitoring of Metabolic Activity Profiles of Peripheral Blood Mononuclear Cells (PBMC)
- ClinicalTrials.gov ID
- NCT02090166
- Acronym / sponsor ID
- EDLC / CMC-13-0105-CTIL
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Apr 2014
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer diagnosis | Other | Other: Blood test4 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject signed the informed consent.
- Subject is between 18 to 90 years old.
- Lung cancer diagnosis before any treatment
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testa blood test will be taken from each patient | Other | lung cancer diagnosis |
Primary outcome
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yochai Adir, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Lung Cancer, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yochai Adir, MD (+972-4-8250517 ext. 1, yochaiad@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and negative diagnosis (scored 0/1 dichotomously) of lung cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.