- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02891642
Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jian Xu, MD/ PhD
- Phone Number: +8602568135230
- Email: xu_jian79@163.com
Study Locations
-
-
Jiangsu
-
Nanjin, Jiangsu, China, 210029
- Not yet recruiting
- The First Affiliated Hospital with Nanjing Medical University
-
Contact:
- Jian Xu, MD/PHD
- Phone Number: +8602568135230
- Email: xu_jian79@163.com
-
Nanjing, Jiangsu, China, 210029
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
Contact:
- Jian Xu, PhD, MD
- Phone Number: 86-25-68303453
- Email: xu_jian79@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Principal Investigator: Shiyang Pan, MD/ PhD, The First Affiliated Hospital with Nanjing Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Laboratory Medicine-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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