Circulating Tumor Cells Spillage After Pulmonary Biopsy

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: CellCollectorTM (Gilupi, Germany) needle

• Registration Number: NCT02507778
• Lead Sponsor: Rabin Medical Center

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 .

Study Timeline

• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Study Start: 2015-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23
• Primary Completion: 2017-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
biopsy	CellCollectorTM (Gilupi, Germany) needle	needle will be inserted before and after biopsy and will measure circulating tumor cells.

Primary Outcome Measures

Name	Time	Method
Circulating tumor cells (CTCs) before and after the procedure.	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).

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel