- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00772200
Neuropsykologisk og adfærdsmæssig testning hos yngre patienter med kræft
Neuropsykologiske, sociale, følelsesmæssige og adfærdsmæssige resultater hos børn med kræft
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMÆRE MÅL:
I. At indføre procedurer for at sikre en konsistent, strømlinet og effektiv administration af de neuropsykologiske/adfærdsmæssige tests i en samarbejdsgruppe for at maksimere overholdelse af et standardiseret vurderingsbatteri udført på 3 standardiserede tidspunkter.
OMRIDS:
Forældre- og børnedeltagere fuldfører COG Standard Neuropsychological and Behavioral Battery ca. 9, 30 og 60 måneder efter diagnosen i en 1-2 timers testsession udført af en neuropsykolog eller psykolog. Batteriet består af mål for intelligens, behandlingshastighed, opmærksomhed, hukommelse, sprogpræference, adfærdsmæssig/social/emotionel funktion, eksekutiv funktion, adaptiv funktion og livskvalitet.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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New South Wales
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Hunter Regional Mail Centre, New South Wales, Australien, 2310
- John Hunter Children's Hospital
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Randwick, New South Wales, Australien, 2031
- Sydney Children's Hospital
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Westmead, New South Wales, Australien, 2145
- The Children's Hospital at Westmead
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Queensland
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Herston, Queensland, Australien, 4029
- Royal Children's Hospital-Brisbane
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South Brisbane, Queensland, Australien, 4101
- Queensland Children's Hospital
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South Australia
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North Adelaide, South Australia, Australien, 5006
- Women's and Children's Hospital-Adelaide
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Victoria
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Parkville, Victoria, Australien, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australien, 6008
- Princess Margaret Hospital for Children
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Perth, Western Australia, Australien, 6009
- Perth Children's Hospital
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's 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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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, H3T 1C5
- Centre Hospitalier Universitaire Sainte-Justine
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham Cancer Center
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Birmingham, Alabama, Forenede Stater, 35233
- Children's Hospital of Alabama
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Arizona
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Mesa, Arizona, Forenede Stater, 85202
- Cardon Children's Medical Center
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Childrens Hospital
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California
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Downey, California, Forenede Stater, 90242
- Kaiser Permanente Downey Medical Center
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Long Beach, California, Forenede Stater, 90806
- Miller Children's and Women's Hospital Long Beach
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90095
- Mattel Children's Hospital UCLA
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Madera, California, Forenede Stater, 93636
- Valley Children's Hospital
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente-Oakland
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Oakland, California, Forenede Stater, 94609-1809
- Children's Hospital and Research Center at Oakland
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Palo Alto, California, Forenede Stater, 94304
- Lucile Packard Children's Hospital Stanford University
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San Diego, California, Forenede Stater, 92123
- Rady Children's Hospital - San Diego
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San Francisco, California, Forenede Stater, 94158
- UCSF Medical Center-Mission Bay
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San Francisco, California, Forenede Stater, 94143
- UCSF Medical Center-Parnassus
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Torrance, California, Forenede Stater, 90502
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Children's Hospital Colorado
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Connecticut
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Hartford, Connecticut, Forenede Stater, 06106
- Connecticut Children's Medical Center
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Alfred I duPont Hospital for Children
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward Health Medical Center
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Fort Myers, Florida, Forenede Stater, 33908
- Golisano Children's Hospital of Southwest Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Lee Memorial Health System
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Gainesville, Florida, Forenede Stater, 32610
- University of Florida Health Science Center - Gainesville
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
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Jacksonville, Florida, Forenede Stater, 32207
- Nemours Children's Clinic-Jacksonville
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Miami, Florida, Forenede Stater, 33155
- Nicklaus Children's Hospital
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Miami, Florida, Forenede Stater, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Orlando, Florida, Forenede Stater, 32806
- Nemours Children's Clinic - Orlando
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Orlando, Florida, Forenede Stater, 32827
- Nemours Children's Hospital
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Orlando, Florida, Forenede Stater, 32803
- AdventHealth Orlando
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Orlando, Florida, Forenede Stater, 32806
- Arnold Palmer Hospital for Children
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Orlando, Florida, Forenede Stater, 32806
- UF Cancer Center at Orlando Health
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Pensacola, Florida, Forenede Stater, 32504
- Nemours Children's Clinic - Pensacola
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St. Petersburg, Florida, Forenede Stater, 33701
- Johns Hopkins All Children's Hospital
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Tampa, Florida, Forenede Stater, 33606
- Tampa General Hospital
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Tampa, Florida, Forenede Stater, 33607
- Saint Joseph's Hospital/Children's Hospital-Tampa
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West Palm Beach, Florida, Forenede Stater, 33407
- Saint Mary's Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Children's Healthcare of Atlanta - Egleston
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Savannah, Georgia, Forenede Stater, 31404
- Memorial Health University Medical Center
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Hawaii
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Honolulu, Hawaii, Forenede Stater, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Forenede Stater, 96826
- Kapiolani Medical Center for Women and Children
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Mountain States Tumor Institute
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Lurie Children's Hospital-Chicago
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Oak Lawn, Illinois, Forenede Stater, 60453
- Advocate Children's Hospital-Oak Lawn
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Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Lutheran General Hospital
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Park Ridge, Illinois, Forenede Stater, 60068
- Advocate Children's Hospital-Park Ridge
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Peoria, Illinois, Forenede Stater, 61637
- Saint Jude Midwest Affiliate
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Riley Hospital for Children
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Indianapolis, Indiana, Forenede Stater, 46260
- Saint Vincent Hospital and Health Care Center
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Iowa
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Des Moines, Iowa, Forenede Stater, 50309
- Blank Children's Hospital
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky/Markey Cancer Center
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Louisville, Kentucky, Forenede Stater, 40202
- Norton Children's Hospital
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121
- Ochsner Medical Center Jefferson
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New Orleans, Louisiana, Forenede Stater, 70118
- Children's Hospital New Orleans
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital Cancer Center
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Boston, Massachusetts, Forenede Stater, 02111
- Floating Hospital for Children at Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- C S Mott Children's Hospital
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, Forenede Stater, 48236
- Ascension Saint John Hospital
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East Lansing, Michigan, Forenede Stater, 48824-7016
- Michigan State University Clinical Center
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Grand Rapids, Michigan, Forenede Stater, 49503
- Helen DeVos Children's Hospital at Spectrum Health
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49008
- Kalamazoo Center for Medical Studies
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55404
- Children's Hospitals and Clinics of Minnesota - Minneapolis
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota/Masonic Cancer Center
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospitals and Clinics
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89144
- Summerlin Hospital Medical Center
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Las Vegas, Nevada, Forenede Stater, 89109
- Sunrise Hospital and Medical Center
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Las Vegas, Nevada, Forenede Stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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Livingston, New Jersey, Forenede Stater, 07039
- Saint Barnabas Medical Center
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Morristown, New Jersey, Forenede Stater, 07960
- Morristown Medical Center
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New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
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Newark, New Jersey, Forenede Stater, 07112
- Newark Beth Israel Medical Center
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Paterson, New Jersey, Forenede Stater, 07503
- Saint Joseph's Regional Medical Center
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Summit, New Jersey, Forenede Stater, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, Forenede Stater, 87102
- University of New Mexico Cancer Center
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New York
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Albany, New York, Forenede Stater, 12208
- Albany Medical Center
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
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New Hyde Park, New York, Forenede Stater, 11040
- The Steven and Alexandra Cohen Children's Medical Center of New York
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New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Forenede Stater, 10029
- Mount Sinai Hospital
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New York, New York, Forenede Stater, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
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New York, New York, Forenede Stater, 10016
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
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The Bronx, New York, Forenede Stater, 10467
- Montefiore Medical Center - Moses Campus
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Valhalla, New York, Forenede Stater, 10595
- New York Medical College
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital
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Chapel Hill, North Carolina, Forenede Stater, 27599
- UNC Lineberger Comprehensive Cancer Center
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Charlotte, North Carolina, Forenede Stater, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, Forenede Stater, 28204
- Novant Health Presbyterian Medical Center
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Health Sciences
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, Forenede Stater, 44308
- Children's Hospital Medical Center of Akron
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Forenede Stater, 44106
- Rainbow Babies and Childrens Hospital
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Columbus, Ohio, Forenede Stater, 43205
- Nationwide Children's Hospital
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Dayton, Ohio, Forenede Stater, 45404
- Dayton Children's Hospital
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Toledo, Ohio, Forenede Stater, 43606
- The Toledo Hospital/Toledo Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97227
- Legacy Emanuel Children's Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Lehigh Valley Hospital - Muhlenberg
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Hershey, Pennsylvania, Forenede Stater, 17033
- Penn State Children's Hospital
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19134
- Saint Christopher's Hospital for Children
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Children's Hospital of Pittsburgh of UPMC
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Rhode Island Hospital
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29203
- Prisma Health Richland Hospital
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Greenville, South Carolina, Forenede Stater, 29605
- BI-LO Charities Children's Cancer Center
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Cancer Treatment Center
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57117-5134
- Sanford USD Medical Center - Sioux Falls
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- T C Thompson Children's Hospital
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Knoxville, Tennessee, Forenede Stater, 37916
- East Tennessee Childrens Hospital
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University/Ingram Cancer Center
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Texas
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Austin, Texas, Forenede Stater, 78723
- Dell Children's Medical Center of Central Texas
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Forenede Stater, 75230
- Medical City Dallas Hospital
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Lubbock, Texas, Forenede Stater, 79410
- Covenant Children's Hospital
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San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Forenede Stater, 78207
- Children's Hospital of San Antonio
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San Antonio, Texas, Forenede Stater, 78229
- Methodist Children's Hospital of South Texas
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Primary Children's Hospital
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Vermont
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Burlington, Vermont, Forenede Stater, 05405
- University of Vermont and State Agricultural College
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Cancer Center
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Norfolk, Virginia, Forenede Stater, 23507
- Children's Hospital of The King's Daughters
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Roanoke, Virginia, Forenede Stater, 24014
- Carilion Clinic Children's Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's Hospital
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Spokane, Washington, Forenede Stater, 99204
- Providence Sacred Heart Medical Center and Children's Hospital
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25304
- West Virginia University Charleston Division
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Morgantown, West Virginia, Forenede Stater, 26506
- West Virginia University Healthcare
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Wisconsin
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Green Bay, Wisconsin, Forenede Stater, 54301
- Saint Vincent Hospital Cancer Center Green Bay
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Madison, Wisconsin, Forenede Stater, 53792
- University of Wisconsin Hospital and Clinics
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Children's Hospital of Wisconsin
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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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, 00926
- University Pediatric Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Patienten skal i øjeblikket være tilmeldt eller planlægge at blive tilmeldt en COG-terapeutisk undersøgelse, der har til formål at undersøge neuropsykologisk, social, følelsesmæssig og/eller adfærdsmæssig funktion
- Patienten skal have receptive og ekspressive sprogfærdigheder på engelsk, fransk eller spansk; hvis en patient opfylder disse kriterier, men forælderen/værgen taler et andet sprog end engelsk, fransk eller spansk, kan patienten stadig være tilmeldt og testet, og forældrerapporteringsforanstaltningerne bør udelades
- Alle patienter og/eller deres forældre eller værger skal underskrive et skriftligt informeret samtykke
- Alle institutionelle krav, Food and Drug Administration (FDA) og National Cancer Institute (NCI) krav til humane undersøgelser skal være opfyldt
Ekskluderingskriterier:
- Patienter med en anamnese med moderat til alvorlig intellektuel funktionsnedsættelse (dvs. intelligenskvotient [IQ] =< 55) er ikke berettiget til tilmelding; BEMÆRK VENLIGST: Børn med en tidligere historie med opmærksomhedsunderskud hyperaktivitetsforstyrrelse (ADHD) eller en specifik indlæringsvanskelighed (f.eks. ordblindhed) er kvalificerede til denne undersøgelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Observationelle (neuropsykologiske og adfærdsmæssige tests)
Forældre- og børnedeltagere fuldfører COG Standard Neuropsychological and Behavioral Battery ca. 9, 30 og 60 måneder efter diagnosen i en 1-2 timers testsession udført af en neuropsykolog eller psykolog.
Batteriet består af mål for intelligens, behandlingshastighed, opmærksomhed, hukommelse, sprogpræference, adfærdsmæssig/social/emotionel funktion, eksekutiv funktion, adaptiv funktion og livskvalitet.
|
Hjælpestudier
Andre navne:
Komplet COG standard neuropsykologisk og adfærdsmæssigt batteri
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overholdelsesgrad for færdiggørelse af neuropsykologisk og adfærdsmæssigt batteri
Tidsramme: Op til 72 måneder efter diagnosen
|
Op til 72 måneder efter diagnosen
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Leanne M Embry, Children's Oncology Group
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALTE07C1 (Anden identifikator: CTEP)
- U10CA180886 (U.S. NIH-bevilling/kontrakt)
- U10CA098543 (U.S. NIH-bevilling/kontrakt)
- UG1CA189955 (U.S. NIH-bevilling/kontrakt)
- UG1CA189958 (U.S. NIH-bevilling/kontrakt)
- NCI-2009-00383 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CDR0000594326
- COG-ALTE07C1
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