A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT00355316|
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Other: Blood draw|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients|
|Study Start Date :||November 2005|
|Primary Completion Date :||November 2012|
|Study Completion Date :||February 2013|
Experimental: Stage IV Breast Cancer
Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.
|Other: Blood draw|
Baseline blood draw.
|Other: Blood draw|
- The prevalence of breast cancer cells in the peripheral blood [ Time Frame: 1 year ]Specifically, it is predicted that 60% of subjects with Stage IV breast cancer will have evidence of breast cancer cells in the peripheral blood by multi-marker real-time RT-PCR analysis, and that these subjects will experience a significantly decreased progression-free and overall survival.
- Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy. [ Time Frame: Until patient death ]Specifically, we will determine if molecular detection of circulating breast cancer cells after the initiation of systemic therapy is associated with a significantly decreased progression-free and overall survival.
- Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers [ Time Frame: Approximately 12 weeks ]Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.
- Compare molecular analyses to the results of the CellSeach assay [ Time Frame: Approximately 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355316
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||William E. Gillanders, M.D.||Washington University School of Medicine|