Lung CancerNCT02507778
Circulating Tumor Cells Spillage After Pulmonary Biopsy
A study testing CellCollectorTM (Gilupi, Germany) needle in people with Lung Cancer, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CellCollectorTM (Gilupi, Germany) needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2015to Sep 2019
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of lung cancer
- Patients are designated to undertake biopsy
- Able and willing to participate in this study
- Availability of a signed informed consent
Who cannot join
- Any recent non-lung cancer in the recent 2 years.
Trial locations and contacts
1 site in 1 country.
Nir Peled, MD PhD FCCP contact
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
Nir Peled, MD PhD FCCP, nirp@clalit.org.il
About this study
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
Read the detailed description
Introduction:
Lung cancer (NSCLC) is a common malignancy with a high recurrence rate even when diagnosed at early stages. Biopsy is currently the procedure of choice for the investigation of pulmonary lesions, yet it is unclear whether the biopsy itself releases tumor cells into the circulation and attributes to the late distal recurrence.
Studies of various malignancies show the ability to identify circulating tumor cells (CTCs) even in early stage cancer. The number of CTCs correlates with disease outcome. Dynamics of CTCs after CT or bronchoscopy guided biopsy has not been evaluated so far. In the metastatic setting, the number of CTCs correlates to tumor response to chemotherapy in both small and non-small lung cancer (SCLC and NSCLC, respectively).
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
Patients with suspected pulmonary lesions undergoing CT or bronchoscopy guided biopsy will be enrolled into the study. The CellCollectorTM will be used for CTCs detection before and after the procedure. These patients will be their own controls.
In this study the investigators will use the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM). This technology enables high quality immunohistochemical and molecular testing of the acquired cells as needed for treatment planning, and even allows cell culture growth from the live CTCs. This device is certified for use throughout Europe, with no adverse events noted with its usage .
- Conditions
- Lung Cancer
- Being tested
- CellCollectorTM (Gilupi, Germany) needle
- Keywords
- Lung, Cancer, Biomarkers, Early detection, Circulating tumor cell
- Medical subject headings
- Lung Neoplasms, Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellCollectorTM (Gilupi, Germany) needleDevice
needle will be inserted before and after biopsy and will measure circulating tumor cells.
| Study group | Role | What they receive |
|---|---|---|
| biopsy | Other | needle will be inserted before and after biopsy and will measure circulating tumor cells. Receives: Device: CellCollectorTM (Gilupi, Germany) needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cells (CTCs) before and after the procedure.
In this study we will use for CTC counting the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2019 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nir Peled, Rabin Medical Center
- Investigators
- Nir Peled, MD PhD FCCP, Principal investigator, nirp@clalit.org.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507778
- Sponsor's protocol ID
- 0468-14-RMC
- Status last verified
- Sep 2016
- First submitted
- 14 Jul 2015
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells Spillage After Pulmonary Biopsy
- ClinicalTrials.gov ID
- NCT02507778
- Acronym / sponsor ID
- 0468-14-RMC
- Conditions
- Lung Cancer
- Keywords
- Lung, Cancer, Biomarkers, Early detection, Circulating tumor cell
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 24 Jul 2015 (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.
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
Detailed description
Introduction:
Lung cancer (NSCLC) is a common malignancy with a high recurrence rate even when diagnosed at early stages. Biopsy is currently the procedure of choice for the investigation of pulmonary lesions, yet it is unclear whether the biopsy itself releases tumor cells into the circulation and attributes to the late distal recurrence.
Studies of various malignancies show the ability to identify circulating tumor cells (CTCs) even in early stage cancer. The number of CTCs correlates with disease outcome. Dynamics of CTCs after CT or bronchoscopy guided biopsy has not been evaluated so far. In the metastatic setting, the number of CTCs correlates to tumor response to chemotherapy in both small and non-small lung cancer (SCLC and NSCLC, respectively).
The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.
Patients with suspected pulmonary lesions undergoing CT or bronchoscopy guided biopsy will be enrolled into the study. The CellCollectorTM will be used for CTCs detection before and after the procedure. These patients will be their own controls.
In this study the investigators will use the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM). This technology enables high quality immunohistochemical and molecular testing of the acquired cells as needed for treatment planning, and even allows cell culture growth from the live CTCs. This device is certified for use throughout Europe, with no adverse events noted with its usage .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy | Other | Device: CellCollectorTM (Gilupi, Germany) needleneedle will be inserted before and after biopsy and will measure circulating tumor cells. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of lung cancer
- Patients are designated to undertake biopsy
- Able and willing to participate in this study
- Availability of a signed informed consent
Key exclusion criteria (1 listed)
- Any recent non-lung cancer in the recent 2 years.
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 |
|---|---|---|
| CellCollectorTM (Gilupi, Germany) needleneedle will be inserted before and after biopsy and will measure circulating tumor cells. | Device | biopsy |
Primary outcome
Circulating tumor cells (CTCs) before and after the procedure.
Time frame: 1 day
In this study we will use for CTC counting the CellCollectorTM (Gilupi, Germany) needle that isolates CTCs of epithelial origin using a needle coated with antibodies directed against the epithelial cell adhesion molecules (EpCAM).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Nir Peled, MD PhD FCCP contact
Nir Peled, MD PhD FCCP principal investigator
nirp@clalit.org.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellCollectorTM (Gilupi, Germany) needle in people with Lung Cancer, run by Rabin 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 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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 Nir Peled, MD PhD FCCP (nirp@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cells (CTCs) before and after the procedure. (time frame: 1 day). 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 23 Sep 2016.