- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899275
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
A Children?s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. To collect biological specimens from patients with osteosarcoma at Children?s Oncology Group (COG) institutions.
II. To provide a repository for long-term storage of osteosarcoma-related biological materials.
III. To make these specimens available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patients' clinical data.
OUTLINE:
After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material. Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples). Autopsy tumor samples may also be submitted.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Queensland
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Herston, Queensland, Australia, 4029
- Royal Brisbane and Women's Hospital
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Herston, Queensland, Australia, 4029
- Royal Children's Hospital-Brisbane
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South Brisbane, Queensland, Australia, 4101
- Queensland Children's Hospital
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South Australia
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North Adelaide, South Australia, Australia, 5006
- Women's and Children's Hospital-Adelaide
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Western Australia
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Perth, Western Australia, Australia, 6008
- Princess Margaret Hospital for Children
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
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Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3V4
- British Columbia Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3H 1P3
- The Montreal Children's Hospital of the MUHC
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Montreal, Quebec, Canada, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Auckland
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Grafton, Auckland, New Zealand, 1145
- Starship Children's Hospital
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San Juan, Puerto Rico, 00912
- San Jorge Children's Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Childrens Hospital
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, United States, 72202-3591
- Arkansas Children's Hospital
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California
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Downey, California, United States, 90242
- Kaiser Permanente Downey Medical Center
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Duarte, California, United States, 91010
- City of Hope Comprehensive Cancer Center
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Loma Linda, California, United States, 92354
- Loma Linda University Medical Center
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Long Beach, California, United States, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
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Los Angeles, California, United States, 90095
- Mattel Children's Hospital UCLA
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Madera, California, United States, 93636
- Valley Children's Hospital
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Oakland, California, United States, 94611
- Kaiser Permanente-Oakland
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Oakland, California, United States, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Palo Alto, California, United States, 94304
- Lucile Packard Children's Hospital Stanford University
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San Diego, California, United States, 92123
- Rady Children's Hospital - San Diego
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San Diego, California, United States, 92134
- Naval Medical Center -San Diego
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San Francisco, California, United States, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, United States, 94143
- UCSF Medical Center-Parnassus
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, United States, 06520
- Yale University
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Delaware
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Wilmington, Delaware, United States, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Fort Myers, Florida, United States, 33908
- Golisano Children's Hospital of Southwest Florida
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Fort Myers, Florida, United States, 33901
- Lee Memorial Health System
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Hollywood, Florida, United States, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, United States, 33176
- Miami Cancer Institute
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Orlando, Florida, United States, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, United States, 32827
- Nemours Children's Hospital
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Orlando, Florida, United States, 32803
- AdventHealth Orlando
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Orlando, Florida, United States, 32806
- Arnold Palmer Hospital for Children
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Orlando, Florida, United States, 32806
- UF Cancer Center at Orlando Health
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Pensacola, Florida, United States, 32504
- Nemours Children's Clinic - Pensacola
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Saint Petersburg, Florida, United States, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, United States, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, United States, 33407
- Saint Mary's Hospital
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston
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Savannah, Georgia, United States, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, United States, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, United States, 83712
- Saint Luke's Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, United States, 60612
- University of Illinois
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Chicago, Illinois, United States, 60611
- Lurie Children's Hospital-Chicago
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Oak Lawn, Illinois, United States, 60453
- Advocate Children's Hospital-Oak Lawn
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Peoria, Illinois, United States, 61637
- Saint Jude Midwest Affiliate
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Springfield, Illinois, United States, 62702
- Southern Illinois University School of Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, United States, 46260
- Saint Vincent Hospital and Health Care Center
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, United States, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, United States, 70112
- Tulane University Health Sciences Center
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, United States, 21215
- Sinai Hospital of Baltimore
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, United States, 02111
- Floating Hospital For Children at Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, United States, 48236
- Ascension Saint John Hospital
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East Lansing, Michigan, United States, 48824-7016
- Michigan State University Clinical Center
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Flint, Michigan, United States, 48503
- Hurley Medical Center
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Grand Rapids, Michigan, United States, 49503
- Helen DeVos Children's Hospital at Spectrum Health
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Kalamazoo, Michigan, United States, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, United States, 49008
- Kalamazoo Center for Medical Studies
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, United States, 39216
- University of Mississippi Medical Center
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Missouri
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Columbia, Missouri, United States, 65201
- Columbia Regional
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospitals and Clinics
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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Omaha, Nebraska, United States, 68114
- Children's Hospital and Medical Center of Omaha
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Nevada
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Las Vegas, Nevada, United States, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, United States, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, United States, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, United States, 89102
- University Medical Center of Southern Nevada
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Las Vegas, Nevada, United States, 89106
- Nevada Cancer Research Foundation CCOP
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New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, United States, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, United States, 07503
- Saint Joseph's Regional Medical Center
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Summit, New Jersey, United States, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Cancer Center
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center - Moses Campus
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Brooklyn, New York, United States, 11201
- Brooklyn Hospital Center
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New Hyde Park, New York, United States, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, United States, 10029
- Mount Sinai Hospital
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New York, New York, United States, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, United States, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, United States, 14642
- University of Rochester
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Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
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Valhalla, New York, United States, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital Inc-Memorial Campus
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Chapel Hill, North Carolina, United States, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, United States, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, United States, 44308
- Children's Hospital Medical Center of Akron
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44106
- Rainbow Babies and Childrens Hospital
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, United States, 45404
- Dayton Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Portland, Oregon, United States, 97227
- Legacy Emanuel Children's Hospital
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Portland, Oregon, United States, 97227
- Legacy Emanuel Hospital and Health Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19134
- Saint Christopher's Hospital for Children
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Philadelphia, Pennsylvania, United States, 19104
- Childrens Oncology Group
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Pittsburgh, Pennsylvania, United States, 15224
- Children's Hospital of Pittsburgh of UPMC
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Columbia, South Carolina, United States, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, United States, 29605
- BI-LO Charities Children's Cancer Center
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Greenville, South Carolina, United States, 29605
- Greenville Cancer Treatment Center
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South Dakota
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Sioux Falls, South Dakota, United States, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, United States, 37916
- East Tennessee Childrens Hospital
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Nashville, Tennessee, United States, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Austin, Texas, United States, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, United States, 78411
- Driscoll Children's Hospital
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Dallas, Texas, United States, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Fort Sam Houston, Texas, United States, 78234
- Brooke Army Medical Center
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States, 78229
- Methodist Children's Hospital of South Texas
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Temple, Texas, United States, 76508
- Scott and White Memorial Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, United States, 05405
- University of Vermont and State Agricultural College
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507
- Children's Hospital of The King's Daughters
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Roanoke, Virginia, United States, 24014
- Carilion Clinic Children's Hospital
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Spokane, Washington, United States, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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Tacoma, Washington, United States, 98431
- Madigan Army Medical Center
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West Virginia
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Charleston, West Virginia, United States, 25304
- West Virginia University Charleston Division
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Morgantown, West Virginia, United States, 26506
- West Virginia University Healthcare
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All osteosarcoma patients seen at COG institutions are eligible, including the following:
- Newly diagnosed patients
- Patients with recurrent disease who were not enrolled at the time of diagnosis
The following specimens from the initial biopsy (and/or definitive surgery if an up-front resection is performed) are required:
- Paraffin embedded block OR 30 unstained slides
- Pretreatment blood consisting of 5 mL serum, 10 mL plasma, and 10 mL heparinized whole blood
- Fresh and frozen tumor specimens
- Patients are not required to enter a therapeutic study to enroll on this study
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-correlative
After the initial submission of blood samples, patients may undergo open or closed biopsy in order to obtain fresh and frozen tissue samples as well as paraffin embedded material.
Patients who are enrolled at the time of initial diagnosis but then have a definitive surgery or develop recurrent disease may submit additional samples (paraffin block, frozen and fresh tumor tissue, or slides together with blood samples).
Autopsy tumor samples may also be submitted.
|
Correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collection of biological specimens from patients with osteosarcoma
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard G Gorlick, Children's Oncology Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOST06B1 (Other Identifier: CTEP)
- U10CA098543 (U.S. NIH Grant/Contract)
- UG1CA189958 (U.S. NIH Grant/Contract)
- NCI-2009-00410 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000562538
- COG-AOST06B1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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