Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool

NCT ID: NCT02172027

Last Updated: 2016-09-15

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-09-30

Brief Summary

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Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. These cells can then be used to prepare a cell block for staining and further tests.

In some research despite clinical suspicions, the cytological diagnosis is negative, due to the specimen containing too few cells or damage to the cells whilst the specimen is processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation. Using this method, an antigen binds to proteins in the cell wall that are unique to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the cells with the magnetic tags from the remainder of the cells. The separated cells can then be stained or cultured.

The currently approved method of immunomagnetic detection has been approved for clinical use in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli Biotech company has developed an advanced technology that allows identification of a larger number of cells without causing morphological damage to the cells.

The purpose of the current study is to examine the technique of immunomagnetic separation in pleural effusion of lung cancer patients in comparison to the cytological tests. In the future it is hoped that a larger number of patient samples will be included and further characterization of the cells will be possible to be compared to the clinical and cytological characteristics.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung Cancer, Pleural effusion

Immunomagnetic Detection

Intervention Type DEVICE

Analysis of pleural effusion through immunomagnetic detection device.

Interventions

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Immunomagnetic Detection

Analysis of pleural effusion through immunomagnetic detection device.

Intervention Type DEVICE

Other Intervention Names

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BioCep

Eligibility Criteria

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Inclusion Criteria

* Age 18 and over
* Lung Cancer Patients in the Lung Department or Oncology Department with spread to the pleural cavity.

Exclusion Criteria

* Under age 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ImmunoMag-Det LC 00432014

Identifier Type: -

Identifier Source: org_study_id

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