Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer
Tracking Information | |||||
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | July 27, 2012 | ||||
Start Date ICMJE | October 2005 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To detect and count cancer cells in the blood of patients who have recently been diagnosed with a recurrent breast cancer. [ Time Frame: 26 Months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00493350 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
To learn if the detection of circulating cancer cells is a predictor for a worse disease prognosis. [ Time Frame: 26 Months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
Perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Prospective Validation Trial of Circulating Tumor Cells (CTCs) in Women With Metastatic Breast Cancer | ||||
Official Title ICMJE | International Stage IV Stratification Study (ISSS): Prospective Validation Trial of Circulating Tumor Cells (CTCs) as Prognostic and Predictive Markers in Women With Metastatic Breast Cancer About to Start First-Line Treatment | ||||
Brief Summary | Primary Objectives:
Secondary Objective: 1. To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes. |
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Detailed Description | Patients with tumors that have spread to other parts of the body and who are about to start systemic treatment will be eligible to take part in this study. As is standard of care, you will have an evaluation of your disease through CT scans, bone scans, and PET scans. Before you begin your routine treatment, participants in this study will have 3 teaspoons of blood drawn at an M. D. Anderson clinic. This will be the only blood draw required for this study. You will then begin receiving standard therapy for your disease as decided by your treating physician. You will have follow-ups with either your physician or through the research personnel (by phone calls by the research nurse) at 3, 6, 12, 18, and 36 months. After 36 months, follow-up will continue indefinitely at your doctor's discretion. At these follow-ups, your medical record will be reviewed to gather information for this study. One of the blood samples will be preserved and used for research and development purposes specifically related to this study. This research includes also analysis of the tumor gene profiling. This study will be done to better understand the biology of metastatic breast cancer. Neither participants nor the doctors taking care of them will be told about the results of the research. This is an investigational study. CellSearch (the technology used to count circulating tumor cells) is approved by the FDA for breast cancer prognosis. About 660 patients will take part in this multicenter study. About 100 patients will be enrolled at M. D. Anderson. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: Blood collected prior to the initiation of chemotherapy as follows: 1 x 4 ml (serum tube), 2x10 ml (CellSave Tube), and 1x10 ml EDTA (selected centers); To perform global gene profiling on selected specimens and correlate the profiles with clinical outcomes. |
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Sampling Method | Probability Sample | ||||
Study Population | Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy. |
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Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Procedure: Blood Sample
1x4 ml (Serum Tube); 2x10 ml (CellSave Tube); 1x10 ml EDTA (Selected Centers) |
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Study Group/Cohort (s) | 1
Patients with newly diagnosed stage IV breast cancer scheduled to start systemic therapy.
Intervention: Procedure: Blood Sample |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 660 | ||||
Completion Date | December 2007 | ||||
Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493350 | ||||
Other Study ID Numbers ICMJE | 2005-0278 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | Veridex, LLC | ||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | July 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |