Lung CancerNCT02172027
Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool
An observational study of Lung Cancer, run by Meir Medical Center.
Trial summary
Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Immunomagnetic Detection
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Sep 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients with pleural effusion at the Meir Medical Center Oncology Department or Lung Department.
Who may be able to join
- Age 18 and over
- Lung Cancer Patients in the Lung Department or Oncology Department with spread to the pleural cavity.
Who cannot join
- Under age 18
About this study
Official title: Novel Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool
Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. These cells can then be used to prepare a cell block for staining and further tests.
In some research despite clinical suspicions, the cytological diagnosis is negative, due to the specimen containing too few cells or damage to the cells whilst the specimen is processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation. Using this method, an antigen binds to proteins in the cell wall that are unique to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the cells with the magnetic tags from the remainder of the cells. The separated cells can then be stained or cultured.
Read more
The currently approved method of immunomagnetic detection has been approved for clinical use in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli Biotech company has developed an advanced technology that allows identification of a larger number of cells without causing morphological damage to the cells.
The purpose of the current study is to examine the technique of immunomagnetic separation in pleural effusion of lung cancer patients in comparison to the cytological tests. In the future it is hoped that a larger number of patient samples will be included and further characterization of the cells will be possible to be compared to the clinical and cytological characteristics.
- Conditions
- Lung Cancer
- Being tested
- Immunomagnetic Detection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunomagnetic DetectionDevice
Also called BioCep
Analysis of pleural effusion through immunomagnetic detection device.
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer, Pleural effusion | Not described Receives: Device: Immunomagnetic Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the method of Immunomagnetic detection to the current cytological test.
The sample will be sent in parallel for cytological testing and immunomagnetic separation. By comparing the percentage of positive cells identified by the two methods of analysis, it can be determined whether immunomagnetic separation is an efficient method of identifying cancerous cells.
Measured: The samples will analyzed within a year
Secondary outcomes (1)
The sensitivity of the technique of immunomagnetic separation compared to existing cytological techniques.
The sensitivity of the new technique of immunomagnetic separation will be assessed through analysis of the percentage of positive cells identified compared to the gold standard of cytological techniques.
Measured: Within two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Technical problems with the device
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172027
- Sponsor's protocol ID
- ImmunoMag-Det LC 00432014
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool
- ClinicalTrials.gov ID
- NCT02172027
- Acronym / sponsor ID
- ImmunoMag-Det LC 00432014
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical problems with the device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jun 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.
Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. These cells can then be used to prepare a cell block for staining and further tests.
In some research despite clinical suspicions, the cytological diagnosis is negative, due to the specimen containing too few cells or damage to the cells whilst the specimen is processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation. Using this method, an antigen binds to proteins in the cell wall that are unique to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the cells with the magnetic tags from the remainder of the cells. The separated cells can then be stained or cultured.
The currently approved method of immunomagnetic detection has been approved for clinical use in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli Biotech company has developed an advanced technology that allows identification of a larger number of cells without causing morphological damage to the cells.
The purpose of the current study is to examine the technique of immunomagnetic separation in pleural effusion of lung cancer patients in comparison to the cytological tests. In the future it is hoped that a larger number of patient samples will be included and further characterization of the cells will be possible to be compared to the clinical and cytological characteristics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer, Pleural effusion | – | Device: Immunomagnetic Detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients with pleural effusion at the Meir Medical Center Oncology Department or Lung Department.
Key inclusion criteria (2 listed)
- Age 18 and over
- Lung Cancer Patients in the Lung Department or Oncology Department with spread to the pleural cavity.
Key exclusion criteria (1 listed)
- Under age 18
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 |
|---|---|---|
| Immunomagnetic DetectionAlso: BioCepAnalysis of pleural effusion through immunomagnetic detection device. | Device | Lung Cancer, Pleural effusion |
Primary outcome
To compare the method of Immunomagnetic detection to the current cytological test.
Time frame: The samples will analyzed within a year
The sample will be sent in parallel for cytological testing and immunomagnetic separation. By comparing the percentage of positive cells identified by the two methods of analysis, it can be determined whether immunomagnetic separation is an efficient method of identifying cancerous cells.
1 secondary outcome
The sensitivity of the technique of immunomagnetic separation compared to existing cytological techniques.
Time frame: Within two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Meir Medical Center.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the method of Immunomagnetic detection to the current cytological test. (time frame: The samples will analyzed within a 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 15 Sep 2016.