Clinical trial NCT02891642: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignancy
Pleural Effusion
Pleural Diseases
Ascites
Keywords: malignancy
Pleural Effusion
Pleural Neoplasms
Ascites
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: M.D. Anderson Cancer Center
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Jiangsu Cancer Institute & Hospital
name: Anhui Provincial Hospital
name: Sir Run Run Shaw Hospital
name: Renmin Hospital of Wuhan University
name: Xuanwu Hospital, Beijing
First posted: 2016-09-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with serous effusion.

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.

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;

Primary outcomes:
measure: Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)
timeFrame: The samples will be analyzed within 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjin
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shiyang Pan, MD/ PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.