Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Neoplasms

Pleural Effusion

Ascites

Pleural Diseases

Pleural Neoplasms

Respiratory Tract Diseases

Analysis of serous effusion through immunomagnetic detection device

Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.

Immunomagnetic Detection

Jian Xu, MD/ PhD

Jian Xu, PhD, MD

Jian Xu, MD/PHD

Shiyang Pan, MD/ PhD

The purpose of the current study is to establish a Liquid biopsy method (positive enrichment by a novel immunomagnetic beads capture assay) for detection of malignant cell in serous effusions and to evaluate its sensitivity and specificity for clinical application.

A serous effusion is common event in metastatic carcinoma, but it also can be associated with other benign medical conditions. Current standard method for detecting malignancy is by cytological examination. However, cytological examination is often low sensitive, often due to the large amount of fluid with relatively sparse tumor cells present and the presence of many normal cells such as mesothelial cell. The investigators have developed a new method, malignant cell enrichment with immunomagnetic beads capture followed by Pap staining and NGS, to identify target malignant cells in body fluids.

McAb NJ001 is developed for malignant cell isolation with immunomagnetic beads capture technique. This is a prospective, multi-center, double-blind, statistically powered clinical trial that will enroll patients scheduled to undergo a procedure for removal of fluid from a serous effusion with or without clinical diagnosis of caner. The purpose of the current study is to compare the novel serous effusion detection assay using NJ001 coated immunomagnetic beads capture followed by Pap staining and NGS analysis with traditional cytologic evaluation.

Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid

University of California, Los Angeles

M.D. Anderson Cancer Center

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Jiangsu Cancer Institute & Hospital

Anhui Provincial Hospital

Sir Run Run Shaw Hospital

Renmin Hospital of Wuhan University

Xuanwu Hospital, Beijing

The First Affiliated Hospital with Nanjing Medical University

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Analysis of pleural effusion through immunomagnetic detection device.

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.

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

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

The sample will be sent in parallel for cytological testing and immunomagnetic separation. By comparing the percentage of positive cells identified by the two methods of analysis, it can be determined whether immunomagnetic separation is an efficient method of identifying cancerous cells.

The sensitivity of the new technique of immunomagnetic separation will be assessed through analysis of the percentage of positive cells identified compared to the gold standard of cytological techniques.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid	NCT02891642	Malignancy Pleural Effusio... Pleural Disease... Ascites	Immunomagnetic ...	18 Years - 80 Years	The First Affiliated Hospital with Nanjing Medical University
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid	NCT02891642	Malignancy Pleural Effusio... Pleural Disease... Ascites	Immunomagnetic ...	18 Years - 80 Years	The First Affiliated Hospital with Nanjing Medical University
Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool	NCT02172027	Lung Cancer	Immunomagnetic ...	18 Years -	Meir Medical Center

Spots Global Cancer Trial Database for immunomagnetic detection