Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00897338
First received: May 9, 2009
Last updated: December 5, 2013
Last verified: December 2013

May 9, 2009
December 5, 2013
August 2007
June 2014   (final data collection date for primary outcome measure)
  • Feasibility of novel technique to identify and isolate circulating breast cancer cells [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Comparison of this novel technique with the CellSearch™ system [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Feasibility of novel technique to identify and isolate circulating breast cancer cells [ Designated as safety issue: No ]
  • Comparison of this novel technique with the CellSearch™ system [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897338 on ClinicalTrials.gov Archive Site
Not Provided
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Identifying Circulating Breast Cancer Cells in Women With Metastatic Breast Cancer
A Feasibility Study of a Novel Technique to Identify Circulating Breast Cancer Cells in Patients With Metastatic Breast Cancer

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.

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA

Probability Sample

Metastatic breast cancer patients

Breast Cancer
  • Other: flow cytometry
    laboratory analysis
  • Other: fluorescence activated cell sorting
    laboratory analysis
  • Other: immunohistochemistry staining method
    laboratory analysis
  • Other: immunologic technique
    laboratory analysis
  • Other: biomarker analysis
    laboratory analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
June 2014   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast

    • Metastatic disease (stage IV)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Female
18 Years and older
No
United States
 
NCT00897338
J0737 CDR0000571962, P30CA006973, JHOC-J0737
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP