Liquid Biopsy With Immunomagnetic Beads Capture Technique for Malignant Cell Detection in Body Fluid

NCT02891642 | Unknown DMC

• 1 other identifier: Laboratory Medicine-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Malignancy; Pleural Effusion; Pleural Diseases; Ascites

Keywords

malignancy; Pleural Effusion; Pleural Neoplasms; Ascites

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Malignancies Assessed by the Liquid Biopsy with Immunomagnetic Beads Capture Technique (Cancer Cell Positive Enrichment)

  SP70 positive

  The samples will be analyzed within 18 months

Study Arms (1)

Malignancy, Serous effusion

Analysis of serous effusion through immunomagnetic detection device

Device: Immunomagnetic Detection

Interventions

Immunomagnetic Detection DEVICE

Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.

Malignancy, Serous effusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with serous effusion.

You may qualify if:

• 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).

You may not qualify if:

• Females known to be pregnant;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• University of California, Los Angeles: collaborator
• M.D. Anderson Cancer Center: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Jiangsu Cancer Institute & Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (2)

The First Affiliated Hospital with Nanjing Medical University

Nanjin, Jiangsu, 210029, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 22479355 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

body fluid for immunomagnetic separation

MeSH Terms

Conditions

Neoplasms; Pleural Effusion; Pleural Diseases; Ascites; Pleural Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Shiyang Pan, MD/ PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xu, MD/ PhD

CONTACT

+8602568135230; xu_jian79@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 7, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

CN (2)