Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion (GMPE)
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|ClinicalTrials.gov Identifier: NCT01256801|
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment|
|Breast Neoplasms Neoplasm Metastasis Gene Expression Profiling Immunotherapy||Biological: cytokine|
- The patiets with malignant pleural effusion are randomizned to be treated with cytokins(inteleukin 2) or dendritic cells(DC) plus cytokine induced killer cells(CIK) locally.
- Malignant pleural effusion from metastatic breast cancer patient is obtained through thoracentesis and is centrifugalized to enrich cancer cells before the therapy.
- The enriched cancer cells are flash frozen and stored at -80℃ until processing.
- The gene expression in pleural effusion is detected by microarray to screen gene markers that are differently expressed between groups .
- Statistical analysis is performed using unsupervised hierarchical cluster.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||December 2013|
The patients are randomized to receive the cytokine infusion in the pleural cavity
interleukin 2 2 million unit every week
Other Name: interleukin 2 2 million unit every week
- immunotherapy response [ Time Frame: 1 month ]Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
- immunological status [ Time Frame: 1 month ]compare the immunological status of pleural effusion before and after the therapy
Biospecimen Retention: Samples Without 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): NCT01256801
|Beijing Cancer Hospital|
|Beijing, China, 100142|
|Study Chair:||JUN REN, MD||Beijing Cancer Hospital|