NCT02891642

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignancy
• Pleural Effusion
• Pleural Diseases
• Ascites

Interventions

Type	Name	Description
DEVICE	Immunomagnetic Detection	Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.

Timeline

• Start date: 2016-09-01
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2016-09-07
• Last updated: 2020-02-06

Locations

2 sites across 1 country: China