Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- Conditions
- Untreated Childhood Acute Lymphoblastic LeukemiaUntreated Adult Acute Lymphoblastic Leukemia
- Interventions
- Other: laboratory biomarker analysis
- Registration Number
- NCT00482352
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
This clinical trial is studying risk-group classification of patients with newly diagnosed acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical trials.
- Detailed Description
OBJECTIVES:
I. Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL) to a specific treatment clinical trial.
II. Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.
III. Provide a central reference guide for all required and research only ALL studies that will be conducted at local and reference laboratories.
IV. Provide a mechanism for optional banking of leukemia and germline specimens for current and future research.
OUTLINE:
Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).
After completion of induction therapy, patients are followed once or twice annually.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11196
-
Newly diagnosed acute lymphoblastic leukemia, defined by any of the following:
- At least 25% blasts in the bone marrow
- Absolute blast count at least 10,000/mm^3, if bone marrow aspiration is not performed
-
No prior registration on this study
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ancillary-Correlative (marker identification, molecular test) laboratory biomarker analysis Patients undergo blood collection and bone marrow biopsies at baseline and at the end of induction therapy for immunophenotyping for marker identification; molecular testing for translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA ploidy. Immunophenotype results obtained on this study are used to determine the patient's assignment to specific treatment clinical trials (consistent with acute lymphoblastic leukemia).
- Primary Outcome Measures
Name Time Method Development of a classification guide to help determine patient assignment to a specific treatment clinical trial for newly diagnosed acute lymphoblastic leukemia (ALL) Up to 5 years Development of a classification database for correlative studies Up to 5 years Development of a central reference guide for all required and research only ALL studies Up to 5 years Development of a leukemia and germline specimen bank for current and future research Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (200)
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Rainbow Babies and Childrens Hospital
🇺🇸Cleveland, Ohio, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Children's Hospital and Research Center at Oakland
🇺🇸Oakland, California, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Childrens Hospital of Orange County
🇺🇸Orange, California, United States
Lucile Packard Children's Hospital Stanford University
🇺🇸Palo Alto, California, United States
Alfred I duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Lombardi Comprehensive Cancer Center at Georgetown University
🇺🇸Washington, District of Columbia, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Nemours Children's Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Nemours Children's Clinic - Pensacola
🇺🇸Pensacola, Florida, United States
Saint Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
Saint Mary's Hospital
🇺🇸West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston
🇺🇸Atlanta, Georgia, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Advocate Lutheran General Hospital.
🇺🇸Park Ridge, Illinois, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
Saint Jude Midwest Affiliate
🇺🇸Peoria, Illinois, United States
Advocate Children's Hospital-Oak Lawn
🇺🇸Oak Lawn, Illinois, United States
Lurie Children's Hospital-Chicago
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
University of Maryland Greenebaum Cancer Center
🇺🇸Baltimore, Maryland, United States
Cardinal Glennon Children's Medical Center
🇺🇸Saint Louis, Missouri, United States
University of Massachusetts Medical School
🇺🇸Worcester, Massachusetts, United States
Michigan State University - Breslin Cancer Center
🇺🇸Lansing, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States
Kalamazoo Center for Medical Studies
🇺🇸Kalamazoo, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
🇺🇸New Hyde Park, New York, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
UMDNJ - Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Ny Cancer%
🇺🇸Valhalla, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
The Children's Medical Center of Dayton
🇺🇸Dayton, Ohio, United States
Saint Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Weill Medical College of Cornell University
🇺🇸New York, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Mission Hospitals
🇺🇸Asheville, North Carolina, United States
University of Rochester
🇺🇸Rochester, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
State University of New York Upstate Medical University
🇺🇸Syracuse, New York, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Sanford Medical Center-Fargo
🇺🇸Fargo, North Dakota, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
🇺🇸Toledo, Ohio, United States
Mercy Children's Hospital
🇺🇸Toledo, Ohio, United States
Natalie W Bryant Cancer Center
🇺🇸Tulsa, Oklahoma, United States
Lehigh Valley Hospital - Muhlenberg
🇺🇸Bethlehem, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Health Richland
🇺🇸Columbia, South Carolina, United States
Saint Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Texas Tech University Health Science Center-Amarillo
🇺🇸Amarillo, Texas, United States
East Tennessee Childrens Hospital
🇺🇸Knoxville, Tennessee, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
T C Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Greenville Cancer Treatment Center
🇺🇸Greenville, South Carolina, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
Scott and White Memorial Hospital
🇺🇸Temple, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Clinic Children's Hospital
🇺🇸Roanoke, Virginia, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Childrens Hospital-King's Daughters
🇺🇸Norfolk, Virginia, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
West Virginia University Charleston
🇺🇸Charleston, West Virginia, United States
Naval Medical Center - Portsmouth
🇺🇸Portsmouth, Virginia, United States
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Women's and Children's Hospital-Adelaide
🇦🇺North Adelaide, South Australia, Australia
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Starship Children's Hospital
🇳🇿Grafton, Auckland, New Zealand
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Mary Bridge Children's Hospital and Health Center
🇺🇸Tacoma, Washington, United States
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Janeway Child Health Centre
🇨🇦Saint John's, Newfoundland and Labrador, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Swiss Pediatric Oncology Group - Geneva
🇨ðŸ‡Geneva, Switzerland
Children's Hospital
🇨🇦London, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
The Montreal Children's Hospital of the MUHC
🇨🇦Montreal, Quebec, Canada
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Swiss Pediatric Oncology Group - Lausanne
🇨ðŸ‡Lausanne, Switzerland
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Swiss Pediatric Oncology Group - Bern
🇨ðŸ‡Bern, Switzerland
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Nevada Cancer Research Foundation CCOP
🇺🇸Las Vegas, Nevada, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Services
🇺🇸Indianapolis, Indiana, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
University of California San Francisco Medical Center-Parnassus
🇺🇸San Francisco, California, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Phoenix Childrens Hospital
🇺🇸Phoenix, Arizona, United States
Wayne State University-Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
🇺🇸Denver, Colorado, United States
Legacy Emanuel Hospital and Health Center
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Children's Hospital and Medical Center of Omaha
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Saint Joseph Children's Hospital of Tampa
🇺🇸Tampa, Florida, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
University of Hawaii
🇺🇸Honolulu, Hawaii, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
UC Davis Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
C S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Nemours Childrens Clinic - Orlando
🇺🇸Orlando, Florida, United States
UF Cancer Center at Orlando Health
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
The Childrens Mercy Hospital
🇺🇸Kansas City, Missouri, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Children's Hospital-Main Campus
🇺🇸New Orleans, Louisiana, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States