Gene Expression Profiling of Breast Cancer Cells Predict the Response of Malignant Pleural Effusion (GMPE)
Recruitment status was Recruiting
The investigators want to develop a gene expression profile for the prediction of immunotherapy response of patients with metastatic breast cancer presenting malignant pleural effusion.
Gene Expression Profiling
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Gene Expression Profiling of Breast Cancer Cells in Pleural Effusion Prodict the Response of Malignant Pleural Effusion to Immunotherapy|
- immunotherapy response [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Response of malignant pleural effusion to immunotherapy is evaluated with WHO guidelines
- immunological status [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]compare the immunological status of pleural effusion before and after the therapy
Biospecimen Retention: Samples Without DNA
The cancer cells are taken from the malignant pleural effusion of breast cancer patiets.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256801
|Contact: JUN REN, MDfirstname.lastname@example.org|
|Contact: BIN SHAO, MDemail@example.com|
|Beijing Cancer Hospital||Recruiting|
|Beijing, China, 100142|
|Contact: JUN REN, MD and PhD +86-10-88196356 firstname.lastname@example.org|
|Study Chair:||JUN REN, MD||Beijing Cancer Hospital|