Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00089323
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment.
PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I, II, or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry.
Secondary
* Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients.
OUTLINE: This is a multicenter study.
Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry.
Patients are followed every 12 months for up to 10 years.
PROJECTED ACCRUAL: A total of 1,634 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1630
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall survival From time of randomization to death from any cause through 10 years.
- Secondary Outcome Measures
Name Time Method Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods As detected at time of analysis.
Trial Locations
- Locations (53)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Scroll for more (43 remaining)Arkansas Cancer Research Center at University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States