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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malignancy, Serous effusion | Analysis of serous effusion through immunomagnetic detection device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunomagnetic Detection | Device | Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with serous effusion.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Xu, MD/ PhD | Contact | +8602568135230 | xu_jian79@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyang Pan, MD/ PhD | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | Nanjin | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22479355 | Background | 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D001201 | Ascites |
| D010997 | Pleural Neoplasms |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
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| Jiangsu Cancer Institute & Hospital |
| OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Sir Run Run Shaw Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
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body fluid for immunomagnetic separation
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |