Pleural Effusion Clinical Trial
Official title:
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
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.
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