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

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 Overview

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jiangsu
      • Nanjin, Jiangsu, China, 210029
        • Not yet recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with serous effusion.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The samples will be analyzed within 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Laboratory Medicine-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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