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Circulating Tumor Cells Spillage After Pulmonary Biopsy

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CellCollectorTM (Gilupi, Germany) needle
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung, Cancer, Biomarkers, Early detection, Circulating tumor cell

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabin Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

biopsy

Arm Description

needle will be inserted before and after biopsy and will measure circulating tumor cells.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 14, 2015
Last Updated
September 22, 2016
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02507778
Brief Title
Circulating Tumor Cells Spillage After Pulmonary Biopsy
Official Title
Circulating Tumor Cells Spillage After Pulmonary Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung, Cancer, Biomarkers, Early detection, Circulating tumor cell

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
biopsy
Arm Type
Other
Arm Description
needle will be inserted before and after biopsy and will measure circulating tumor cells.
Intervention Type
Device
Intervention Name(s)
CellCollectorTM (Gilupi, Germany) needle
Intervention Description
needle will be inserted before and after biopsy and will measure circulating tumor cells.
Primary Outcome Measure Information:
Title
Circulating tumor cells (CTCs) before and after the procedure.
Description
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).
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nir Peled, MD PhD FCCP
Email
nirp@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nir Peled, MD PhD FCCP
Organizational Affiliation
nirp@clalit.org.il
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nir Peled, MD PhD FCCP
Email
nirp@clalit.org.il

12. IPD Sharing Statement

Plan to Share IPD
No

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Circulating Tumor Cells Spillage After Pulmonary Biopsy

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