An observational study in Malignancy, Pleural Effusion and Pleural Diseases, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.
Browse Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 564 studies on the registry; 312 are open to participants now.
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Patients with serous effusion.
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Exclusion Criteria:
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)
SP70 positive
Time frame: The samples will be analyzed within 18 months
Plan to share: Undecided
The record gives a start of Sep 2016, a primary completion of Feb 2021 and a completion of Feb 2021. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →