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

• Conditions: Pleural Diseases; Malignancy; Ascites; Pleural Effusion
• Interventions: Device: Immunomagnetic Detection

• Registration Number: NCT02891642
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-08-26
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Malignancy, Serous effusion	Immunomagnetic Detection	Analysis of serous effusion through immunomagnetic detection device

Primary Outcome Measures

Name	Time	Method
Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)	The samples will be analyzed within 18 months	SP70 positive

Trial Locations

Locations (2)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjin, Jiangsu, China