Circulating Tumor Cells Spillage After Pulmonary Biopsy

NCT ID: NCT02507778

Last Updated: 2016-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-09-30

Brief Summary

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The aim of this study is to quantify the spillage of tumor cells after biopsy in early lung cancer.

Detailed Description

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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

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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biopsy

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

Group Type OTHER

CellCollectorTM (Gilupi, Germany) needle

Intervention Type DEVICE

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

Interventions

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CellCollectorTM (Gilupi, Germany) needle

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Nir Peled

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nir Peled, MD PhD FCCP

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Nir Peled, MD PhD FCCP

Role: CONTACT

Facility Contacts

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Nir Peled, MD PhD FCCP

Role: primary

Other Identifiers

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0468-14-RMC

Identifier Type: -

Identifier Source: org_study_id

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