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Circulating Tumor Cells Spillage After Pulmonary Biopsy

Circulating Tumor Cells Spillage After Pulmonary Biopsy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02507778
Enrollment
40
Registered
2015-07-24
Start date
2015-09-30
Completion date
2019-09-30
Last updated
2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung, Cancer, Biomarkers, Early detection, Circulating tumor cell

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 .

Interventions

DEVICECellCollectorTM (Gilupi, Germany) needle

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

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Circulating tumor cells (CTCs) before and after the procedure.1 dayIn 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).

Countries

Israel

Contacts

Primary ContactNir Peled, MD PhD FCCP
nirp@clalit.org.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026