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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Malignancy, Pleural Effusion, Pleural Diseases, Ascites

Intervention / Treatment
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* Device: Immunomagnetic Detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females >18 years of age; Have a serous effusion; Scheduled for a diagnostic and/or therapeutic procedure to remove serous fluid ( Puncture of serous cavity). Exclusion Criteria: Females known to be pregnant;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Malignancy, Serous effusion<br>Analysis of serous effusion through immunomagnetic detection device | Device: Immunomagnetic Detection<br>* Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment) | SP70 positive | The samples will be analyzed within 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignancy, Pleural Effusion, Pleural Neoplasms, Ascites