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
- Interventions
- Procedure: Bone Marrow Aspiration
- 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
- Arm && Interventions
Group Intervention Description 1: Bone Marrow Aspiration Bone Marrow Aspiration -
- 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)
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
St. Vincent's Medical Center
🇺🇸Jacksonville, Florida, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Lankenau Cancer Center at Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Cancer Center of Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
CCOP - Main Line Health
🇺🇸Wynnewood, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
American Fork Hospital
🇺🇸American Fork, Utah, United States
Sandra L. Maxwell Cancer Center
🇺🇸Cedar City, Utah, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
United Hospital Center
🇺🇸Clarksburg, West Virginia, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
🇺🇸Parkersburg, West Virginia, United States
CHUM - Hotel Dieu Hospital
🇨🇦Montreal, Quebec, Canada
CHUM - Hopital Saint-Luc
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrement - Quebec
🇨🇦Quebec City, Quebec, Canada
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Union Hospital of Cecil County
🇺🇸Elkton, Maryland, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States