Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion (GMPE)
|ClinicalTrials.gov Identifier: NCT01256801|
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : July 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Neoplasm Metastasis Gene Expression Profiling Immunotherapy||Biological: cytokine||Phase 3|
- 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|
|Primary Completion Date :||January 2013|
|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
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|