- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507778
Circulating Tumor Cells Spillage After Pulmonary Biopsy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nir Peled, MD PhD FCCP
- Email: nirp@clalit.org.il
Study Locations
-
-
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Petach Tikva, Israel, 49100
- Recruiting
- Rabin Medical Center
-
Contact:
- Nir Peled, MD PhD FCCP
- Email: nirp@clalit.org.il
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Any recent non-lung cancer in the recent 2 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: biopsy
needle will be inserted before and after biopsy and will measure circulating tumor cells.
|
needle will be inserted before and after biopsy and will measure circulating tumor cells.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nir Peled, MD PhD FCCP, nirp@clalit.org.il
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0468-14-RMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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