Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment|
|Malignancy Pleural Effusion Pleural Diseases Ascites||Device: Immunomagnetic Detection|
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|
|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|
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.
- 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
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
|Contact: Jian Xu, MD/ PhDemail@example.com|
|The First Affiliated Hospital with Nanjing Medical University||Not yet recruiting|
|Nanjin, Jiangsu, China, 210029|
|Contact: Jian Xu, MD/PHD +8602568135230 firstname.lastname@example.org|
|Principal Investigator:||Shiyang Pan, MD/ PhD||The First Affiliated Hospital with Nanjing Medical University|