Circulating Tumor Cells Spillage After Pulmonary Biopsy

Lung Cancer Clinical Trial

Official title:

Circulating Tumor Cells Spillage After Pulmonary Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02507778
• Other study ID #: 0468-14-RMC
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2015
• Last updated: September 22, 2016
• Start date: September 2015
• Est. completion date: September 2019

Study information

• Verified date: September 2016
• Source: Rabin Medical Center
• Contact: Nir Peled, MD PhD FCCP
• Email: nirp[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2019
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Neoplastic Cells, Circulating

Intervention

Device:
• CellCollectorTM (Gilupi, Germany) needle
needle will be inserted before and after biopsy and will measure circulating tumor cells.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day	No