Circulating Tumor Cells Spillage After Pulmonary Biopsy

Clalit Health Services

Status: Unknown

Conditions: Lung Cancer

Treatments: Device: CellCollectorTM (Gilupi, Germany) needle

Study type: Interventional

Funder types: Other

Identifiers

NCT02507778

0468-14-RMC

Details and patient eligibility

About

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

Full 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 .

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

biopsy

Other group

Description:

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

Treatment:

Device: CellCollectorTM (Gilupi, Germany) needle