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

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ClinicalTrials.gov Identifier: NCT02891642
Recruitment Status : Unknown
Verified August 2016 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
University of California, Los Angeles
M.D. Anderson Cancer Center
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu Cancer Institute & Hospital
Anhui Provincial Hospital
Sir Run Run Shaw Hospital
Renmin Hospital of Wuhan University
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Type : Observational
Estimated 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 : September 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort 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.




Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
body fluid for immunomagnetic separation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with serous effusion.
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891642


Contacts
Contact: Jian Xu, MD/ PhD +8602568135230 xu_jian79@163.com

Locations
China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University Not yet recruiting
Nanjin, Jiangsu, China, 210029
Contact: Jian Xu, MD/PHD    +8602568135230    xu_jian79@163.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
University of California, Los Angeles
M.D. Anderson Cancer Center
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu Cancer Institute & Hospital
Anhui Provincial Hospital
Sir Run Run Shaw Hospital
Renmin Hospital of Wuhan University
Xuanwu Hospital, Beijing
Investigators
Principal Investigator: Shiyang Pan, MD/ PhD The First Affiliated Hospital with Nanjing Medical University

Publications:
Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02891642     History of Changes
Other Study ID Numbers: Laboratory Medicine-001
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
malignancy
Pleural Effusion
Pleural Neoplasms
Ascites

Additional relevant MeSH terms:
Neoplasms
Pleural Effusion
Ascites
Pleural Diseases
Respiratory Tract Diseases
Pathologic Processes