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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02891642

Collaborator

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

1,000

Enrollment

Locations

Duration (Months)

500

Patients Per Site

9.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignancy Pleural Effusion Pleural Diseases Ascites	Device: Immunomagnetic Detection

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Malignancy, Serous effusion Analysis of serous effusion through immunomagnetic detection device	Device: Immunomagnetic Detection Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.

Arm

Intervention/Treatment

Malignancy, Serous effusion

Analysis of serous effusion through immunomagnetic detection device

Device: Immunomagnetic Detection

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210029
2	The First Affiliated Hospital with Nanjing Medical University	Nanjin	Jiangsu	China	210029