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.
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: February 2021
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.
- Device: Immunomagnetic Detection
- Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.
Arms, Groups and Cohorts
- Malignancy, Serous effusion
- Analysis of serous effusion through immunomagnetic detection device
Clinical Trial Outcome Measures
- Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)
- Time Frame: The samples will be analyzed within 18 months
- SP70 positive
Participating in This Clinical Trial
- 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;
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- University of California, Los Angeles
- Provider of Information About this Clinical Study
- Overall Official(s)
- Shiyang Pan, MD/ PhD, Principal Investigator, The First Affiliated Hospital with Nanjing Medical University
- Overall Contact(s)
- Jian Xu, MD/ PhD, +8602568135230, firstname.lastname@example.org
Pan S, Wang F, Huang P, Xu T, Zhang L, Xu J, Li Q, Xia W, Sun R, Huang L, Peng Y, Qin X, Shu Y, Hu Z, Shen H. The study on newly developed McAb NJ001 specific to non-small cell lung cancer and its biological characteristics. PLoS One. 2012;7(3):e33009. doi: 10.1371/journal.pone.0033009. Epub 2012 Mar 30.
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