Spots Global Cancer Trial Database for Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
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Trial Identification
Brief Title: Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Official Title: A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
Study ID: NCT00003854
Conditions
Study Description
Brief Summary: RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.
Detailed Description: OBJECTIVES: * Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer. * Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients. * Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H\&E) staining. * Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H\&E so that these women can be considered as candidates for ACOSOG-Z0011.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Providence Hospital - Mobile AL, Mobile, Alabama, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Washington Regional Medical Center, Fayetteville, Arkansas, United States
St. Vincent Doctors Doctors Hospital, Little Rock, Arkansas, United States
Baptist Health Medical Center, Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Summit Medical Center, Oakland, California, United States
St. Joseph Hospital - Orange, Orange, California, United States
Huntington Memorial Hospital, Pasadena, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Donald N. Sharp Memorial Community Hospital, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Memorial Hospital Cancer Center, Colorado Springs, Colorado, United States
University of Colorado Cancer Center, Denver, Colorado, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Lombardi Cancer Center, Washington, District of Columbia, United States
Morton Plant Mease Health Care, Clearwater, Florida, United States
Lakeland Regional Medical Center, Lakeland, Florida, United States
Watson Clinic, Lakeland, Florida, United States
Bayfront Medical Center, Saint Petersburg, Florida, United States
Martin Memorial Cancer Medical Center, Stuart, Florida, United States
Tallahassee Memorial Healthcare, Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
DeKalb Medical Center, Inc., Decatur, Georgia, United States
St. Francis Medical Center, Honolulu, Hawaii, United States
Kaiser Permanente Medical Center, Honolulu, Hawaii, United States
St. Luke's Regional Medical Center, Boise, Idaho, United States
St. Elizabeth's Hospital, Belleville, Illinois, United States
Belleville Memorial Hospital, Belleville, Illinois, United States
Northwestern University Medical Center, Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
Evanston Northwestern Health Care, Evanston, Illinois, United States
Little Company of Mary Hospital - Evergreen Park, Evergreen Park, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Saint Anthony Memorial Health Center - Michigan City Campus, Michigan City, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Norton Healthcare System, Louisville, Kentucky, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
Woman's Hospital, Baton Rouge, Louisiana, United States
Baton Rouge General Medical Center, Baton Rouge, Louisiana, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
Lahey Clinic - Burlington, Burlington, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
McLaren Regional Cancer Center, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, Michigan, United States
Spectrum Health - Butterworth Campus, Grand Rapids, Michigan, United States
Henry Ford Medical Center - West Bloomfield, West Bloomfield, Michigan, United States
Park Nicollet Clinic, St. Louis Park, Minnesota, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Singing River Hospital, Pascagoula, Mississippi, United States
Columbia Regional Hospital, Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
University of Missouri-Columbia Hospital and Clinics, Columbia, Missouri, United States
St. Louis University Health Sciences Center, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Lester E. Cox Medical Centers, Springfield, Missouri, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital, Mount Holly, New Jersey, United States
Lutheran Medical Center, Brooklyn, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Kingston Hospital, Kingston, New York, United States
Benedictine Hospital, Kingston, New York, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Highland Hospital of Rochester, Rochester, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Durham Regional Hospital, Durham, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cape Fear Valley Health System, Fayetteville, North Carolina, United States
Tri-Health Good Samaritan Hospital, Cincinnati, Ohio, United States
Ireland Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Sacred Heart Hospital, Allentown, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Mercy Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
York Cancer Center, York, Pennsylvania, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Kent County Memorial Hospital, Warwick, Rhode Island, United States
Sarah Cannon-Minnie Pearl Cancer Center, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Baptist Hospital, Nashville, Tennessee, United States
Texas Cancer Center at Brackenridge Hospital, Austin, Texas, United States
Zale Lipshy University Hospital, Dallas, Texas, United States
Simmons Cancer Center - Dallas, Dallas, Texas, United States
St. Paul University Hospital, Dallas, Texas, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Medical Branch, Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Ben Taub General Hospital, Houston, Texas, United States
Methodist Hospital, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Latter Day Saints Hospital, Salt Lake City, Utah, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Carilion New River Valley Medical Center, Christiansburg, Virginia, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Carilion Health System - Cancer Center of Western Virginia, Roanoke, Virginia, United States
Columbia Lewis-Gale Medical Center, Salem, Virginia, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia
Cork University Hospital, Cork, , Ireland
St. Vincent's University Hospital, Dublin, , Ireland
Contact Details
Name: Armando E. Giuliano, MD
Affiliation: Saint John's Cancer Institute
Role: STUDY_CHAIR
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