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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003291 |
Purpose
RATIONALE: The identification of gene mutations may allow doctors to better determine the prognosis of children with acute lymphoblastic leukemia.
PURPOSE: This clinical trial is studying gene mutations to see if they are related to prognosis of cancer in children with acute lymphoblastic leukemia.
| Condition | Intervention |
|---|---|
|
Leukemia |
Genetic: cytogenetic analysis Genetic: mutation analysis Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | Molecular Genetic Lesions and Clinical Outcome in Pediatric ALL Patients |
| Estimated Enrollment: | 200 |
| Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: Patients are stratified by risk (standard vs high).
Bone marrow specimens from patients enrolled in CCG-1922, CCG-1882, or CCG-1901 are analyzed for the following genetic lesions: p16 deletion, p14 deletion, and p15 deletion.
Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.
Patients are followed for at least 3 years.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets criteria for 1 of the following:
Standard risk, as defined by the following:
High risk, as defined by the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Phoenix Children's Hospital | |
| Phoenix, Arizona, United States, 85016 | |
| United States, California | |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Children's Hospital and Research Center - Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93638-8762 | |
| Children's Hospital Los Angeles | |
| Los Angeles, California, United States, 90027-0700 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Santa Barbara Cottage Children's Hospital | |
| Santa Barbara, California, United States, 93102 | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego | |
| San Diego, California, United States, 92120 | |
| Kaiser Permanente Medical Center - Sacramento | |
| Sacramento, California, United States, 95825 | |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | |
| Santa Clara, California, United States, 95051 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| General Robert Huyser Cancer Center at David Grant Medical Center | |
| Travis Air Force Base, California, United States, 94535 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| Children's Hospital Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06360-2875 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010-2970 | |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | |
| Atlanta, Georgia, United States, 30342 | |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | |
| Savannah, Georgia, United States, 31403-3089 | |
| Medical Center of Central Georgia | |
| Macon, Georgia, United States, 31201 | |
| United States, Idaho | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| University of Illinois Cancer Center | |
| Chicago, Illinois, United States, 60612-7243 | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62794-9620 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068-1174 | |
| United States, Indiana | |
| Riley's Children Cancer Center at Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202-5225 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40232 | |
| Markey Cancer Center at University of Kentucky Chandler Medical Center | |
| Lexington, Kentucky, United States, 40536-0293 | |
| United States, Louisiana | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | |
| Baltimore, Maryland, United States, 21215 | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | |
| Springfield, Massachusetts, United States, 01107 | |
| United States, Michigan | |
| Breslin Cancer Center at Ingham Regional Medical Center | |
| Lansing, Michigan, United States, 48910 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007-5364 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| DeVos Children's Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| William Beaumont Hospital - Royal Oak Campus | |
| Royal Oak, Michigan, United States, 48073 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, Nebraska | |
| Children's Hospital of Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-6805 | |
| United States, Nevada | |
| Sunrise Hospital and Medical Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| Valerie Fund Children's Center at Atlantic Health System | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| Brooklyn Hospital Center | |
| Brooklyn, New York, United States, 11201-5493 | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Children's Hospital at Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| Stony Brook University Cancer Center | |
| Stony Brook, New York, United States, 11794-8174 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| United States, North Dakota | |
| Dakota Cancer Institute at Innovis Health - Dakota Clinic | |
| Fargo, North Dakota, United States, 58103-4940 | |
| Roger Maris Cancer Center at MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Columbus Children's Hospital | |
| Columbus, Ohio, United States, 43205-2696 | |
| Children's Medical Center - Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308-1062 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Children's Hospital | |
| Toledo, Ohio, United States, 43601 | |
| United States, Oklahoma | |
| CCOP - Oklahoma | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Doernbecher Children's Hospital at Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Penn State Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Dakota | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | |
| Knoxville, Tennessee, United States, 37901 | |
| East Tennessee State University Cancer Center at Johnson City Medical Center | |
| Johnson City, Tennessee, United States, 37604 | |
| Vanderbilt Children's Hospital | |
| Nashville, Tennessee, United States, 37232-9700 | |
| United States, Texas | |
| CCOP - Scott and White Hospital | |
| Temple, Texas, United States, 76508 | |
| Children's Hospital of Austin | |
| Austin, Texas, United States, 78701 | |
| Covenant Children's Hospital | |
| Lubbock, Texas, United States, 79410 | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| MBCCOP - South Texas Pediatrics | |
| San Antonio, Texas, United States, 78229-3900 | |
| Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75230 | |
| Methodist Cancer Center at Methodist Specialty and Transplant Hospital | |
| San Antonio, Texas, United States, 78229-3902 | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | |
| Amarillo, Texas, United States, 79106 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States, 98105 | |
| Deaconess Medical Center | |
| Spokane, Washington, United States, 99210-0248 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98112 | |
| Madigan Army Medical Center - Tacoma | |
| Tacoma, Washington, United States, 98431-0001 | |
| Mary Bridge Children's Hospital and Health Center - Tacoma | |
| Tacoma, Washington, United States, 98415-0299 | |
| United States, West Virginia | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | |
| Huntington, West Virginia, United States, 25701 | |
| United States, Wisconsin | |
| Bellin Memorial Hospital | |
| Green Bay, Wisconsin, United States, 54301 | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Marshfield Clinic - Marshfield Center | |
| Marshfield, Wisconsin, United States, 54449 | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Australia, New South Wales | |
| Sydney Children's Hospital | |
| Randwick, New South Wales, Australia, 2031 | |
| Australia, Queensland | |
| Royal Children's Hospital | |
| Brisbane, Queensland, Australia, 4029 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6001 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| Children's Hospital of Western Ontario | |
| London, Ontario, Canada, N6C 2V5 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre at Pasqua Hospital | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon Cancer Centre at the University of Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| New Zealand | |
| Starship Children's Health | |
| Auckland, New Zealand | |
| Switzerland | |
| Swiss Pediatric Oncology Group Lausanne | |
| Lausanne, Switzerland, CH 1011 | |
| Swiss Pediatric Oncology Group Geneva | |
| Geneva, Switzerland, CH 1211 | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Study Chair: | Ursula R. Kees, PhD | Telethon Institute for Child Health Research |
More Information
| Study ID Numbers: | CDR0000066224, COG-B969, CCG-B969 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003291 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated childhood acute lymphoblastic leukemia |
|
Lymphatic Diseases Leukemia Neoplasms Leukemia, Lymphoid Immunoproliferative Disorders |
Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Lymphoproliferative Disorders |
