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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 : Recruiting
First Posted : September 7, 2016
Last Update Posted : February 6, 2020
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

Tracking Information
First Submitted Date August 26, 2016
First Posted Date September 7, 2016
Last Update Posted Date February 6, 2020
Study Start Date September 2016
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2020)
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
Original Primary Outcome Measures
 (submitted: September 1, 2016)
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 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Official Title Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
body fluid for immunomagnetic separation
Sampling Method Non-Probability Sample
Study Population Patients with serous effusion.
Condition
  • Malignancy
  • Pleural Effusion
  • Pleural Diseases
  • Ascites
Intervention Device: Immunomagnetic Detection
Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.
Study Groups/Cohorts Malignancy, Serous effusion
Analysis of serous effusion through immunomagnetic detection device
Intervention: Device: Immunomagnetic Detection
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 1, 2016)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility 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;
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jian Xu, MD/ PhD +8602568135230 xu_jian79@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02891642
Other Study ID Numbers Laboratory Medicine-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party The First Affiliated Hospital with Nanjing Medical University
Study Sponsor The First Affiliated Hospital with Nanjing Medical University
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
Investigators
Principal Investigator: Shiyang Pan, MD/ PhD The First Affiliated Hospital with Nanjing Medical University
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date February 2020