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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02891642
• Other study ID #: Laboratory Medicine-001
• Status: Recruiting
• Start date: September 2016
• Est. completion date: February 2021

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Jian Xu, MD/ PhD
• Phone: +8602568135230
• Email: xu_jian79[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Ascites
• Malignancy
• Neoplasms
• Pleural Diseases
• Pleural Effusion

Intervention

Device:
• Immunomagnetic Detection
Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjin	Jiangsu
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (9)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Anhui Provincial Hospital, Jiangsu Cancer Institute & Hospital, M.D. Anderson Cancer Center, Renmin Hospital of Wuhan University, Sir Run Run Shaw Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, University of California, Los Angeles, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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