Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00897338|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : October 12, 2015
RATIONALE: Studying samples of blood and pleural or peritoneal fluid from patients with metastatic breast cancer in the laboratory may help doctors identify biomarkers related to breast cancer and learn more about how breast cancer begins and spreads in the body.
PURPOSE: This research study is looking at a new way of identifying circulating breast cancer cells in blood and in pleural or peritoneal fluid in women with metastatic breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: flow cytometry Other: fluorescence activated cell sorting Other: immunohistochemistry staining method Other: immunologic technique Other: biomarker analysis|
- To compare identification of circulating breast cancer cells (CBCCs) in blood or pleural or peritoneal fluid by a novel technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) to the standard technique using the CellSearch® system in women with metastatic breast cancer.
- To determine whether CBCCs have the potential to grow into metastatic lesions.
OUTLINE: Patients undergo sample collection to help develop a new technique using stem cell marker retinaldehyde dehydrogenase (ALDH) and surface antigen expression (CD44+, CD24-) in isolating circulating breast cancer cells (CBCCs) from blood and pleural or peritoneal fluid. Blood may also be drawn to measure the number of circulating tumor cells using the standard CellSearch® system.
Mononuclear cells are isolated by density centrifugation. Cells are stained against surface antigens that provide specific expression patterns for CBCCs (CD44, CD24). Cells are analyzed on a fluorescence activated cell sorting (FACS) Calibur flow cytometer and sequentially gated (ALDHhigh→CD44+ vs CD24-/low or CD44+ vs CD24-/low→ALDHhigh) for detection of CBCCs. For further confirmation of epithelial origin, ALDHhighCD44+CD24-/low cells are isolated using a FACSAria flow sorter, cytocentrifuged onto glass slides then stained for the expression of epithelial-specific cytokeratins 5, 8, 14, 18 and 19 by standard immunohistochemical techniques. Using the phenotype that is found to most highly enrich for epithelial cells, cells are isolated by FACS and assayed for clonogenic growth.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
- Other: flow cytometry
- Other: fluorescence activated cell sorting
- Other: immunohistochemistry staining method
- Other: immunologic technique
- Other: biomarker analysis
- Feasibility of novel technique to identify and isolate circulating breast cancer cells [ Time Frame: Baseline ]
- Comparison of this novel technique with the CellSearch™ system [ Time Frame: Baseline ]
Biospecimen Retention: Samples With 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): NCT00897338
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-1000|
|Principal Investigator:||Vered Stearns, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|