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Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
Study Purpose
This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 5 Years - 50 Years |
| Gender | All |
Inclusion Criteria:
- - Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1.
- - Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition.
- - Patient must have been diagnosed on or after January 1, 2000.
- - At least 5 years must have elapsed since diagnosis.
- - Patients must have been treated for high-risk neuroblastoma.
- - Note: patients may have had any therapy for high-risk neuroblastoma, including second line or non-established therapies (for example in the setting of less than optimal initial response or concerns for high risk of relapse); patients may have received therapy for refractory or relapsed neuroblastoma, or treatment for an SMN; however all cytotoxic anti-neuroblastoma therapy should have been administered >= 2 years of the enrollment date; SMN therapy may be completed or ongoing at the time of enrollment.
Exclusion Criteria:
- - Patients must not be currently receiving active anti-neuroblastoma cytotoxic chemotherapy.
- - Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the last two years.
- - Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation therapy.
- - Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted at the time of enrollment; for example, patients receiving oral differentiating agents, antiangiogenic therapy, immune modulators, holistic therapies, difluoromethylornithine (DMFO), other minimal residual disease (MRD) therapies/relapse-prevention therapies are eligible.
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03057626 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Tara O Henderson |
| Principal Investigator Affiliation | Children's Oncology Group |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, NIH |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, New Zealand, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Recurrent Neuroblastoma, Stage 2A Neuroblastoma, Stage 2B Neuroblastoma, Stage 3 Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma |
PRIMARY OBJECTIVES:
- I. To estimate the prevalence of organ dysfunction, subsequent malignant neoplasm (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction in a large cohort of representative 5-year survivors of high-risk neuroblastoma treated with modern therapy.
- II. To identify the demographic, clinical and treatment-related risk factors associated with increased risk of organ dysfunction, SMN, growth impairment, abnormal pubertal development and neurobehavioral dysfunction in long-term survivors of high-risk neuroblastoma.
- III. To explore the impact of new biologic therapies and diagnostics including immunotherapy, immunocytokines, isotretinoin (cis-retinoic acid) and iobenguane I-131 (131 I-MIBG) on the risk of late effects.
- IV. To determine the impact of impaired organ function, physical growth, pubertal development, and neurobehavioral function on health-related quality of life (HRQOL) in long-term survivors of high-risk neuroblastoma.
- I. To establish a cohort of high-risk neuroblastoma survivors, with stored peripheral blood samples, who were treated with multi-modal therapies since the year 2000 as a resource for future investigation.
Arms
: Observational (specimen collection)
Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.
Interventions
Other: - Cytology Specimen Collection Procedure
Undergo collection of blood and urine
Other: - Laboratory Biomarker Analysis
Correlative studies
Other: - Quality-of-Life Assessment
Ancillary studies
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764, 35233
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Address
Phoenix Childrens Hospital
Phoenix 5308655, Arizona 5551752, 85016
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Address
Arkansas Children's Hospital
Little Rock 4119403, Arkansas 4099753, 72202-3591
Status
Address
Kaiser Permanente Downey Medical Center
Downey 5343858, California 5332921, 90242
Status
Address
City of Hope Comprehensive Cancer Center
Duarte 5344147, California 5332921, 91010
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Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
Status
Address
UCSF Benioff Children's Hospital Oakland
Oakland 5378538, California 5332921, 94609
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Address
Kaiser Permanente-Oakland
Oakland 5378538, California 5332921, 94611
Status
Address
Lucile Packard Children's Hospital Stanford University
Palo Alto 5380748, California 5332921, 94304
Status
Address
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921, 94158
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Address
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618, 80045
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Address
Connecticut Children's Medical Center
Hartford 4835797, Connecticut 4831725, 06106
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Yale University
New Haven 4839366, Connecticut 4831725, 06520
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Address
Alfred I duPont Hospital for Children
Wilmington 4145381, Delaware 4142224, 19803
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Address
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106, 20010
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Address
Broward Health Medical Center
Fort Lauderdale 4155966, Florida 4155751, 33316
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Address
Golisano Children's Hospital of Southwest Florida
Fort Myers 4155995, Florida 4155751, 33908
Status
Address
University of Florida Health Science Center - Gainesville
Gainesville 4156404, Florida 4155751, 32610
Status
Address
Nemours Children's Clinic-Jacksonville
Jacksonville 4160021, Florida 4155751, 32207
Status
Address
AdventHealth Orlando
Orlando 4167147, Florida 4155751, 32803
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Arnold Palmer Hospital for Children
Orlando 4167147, Florida 4155751, 32806
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Address
Nemours Children's Hospital
Orlando 4167147, Florida 4155751, 32827
Status
Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
Status
Address
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa 4174757, Florida 4155751, 33607
Status
Address
Children's Healthcare of Atlanta - Egleston
Atlanta 4180439, Georgia 4197000, 30322
Status
Address
Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797, 96826
Status
Address
Lurie Children's Hospital-Chicago
Chicago 4887398, Illinois 4896861, 60611
Status
Address
University of Illinois
Chicago 4887398, Illinois 4896861, 60612
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Address
University of Chicago Comprehensive Cancer Center
Chicago 4887398, Illinois 4896861, 60637
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Address
Advocate Children's Hospital-Oak Lawn
Oak Lawn 4904365, Illinois 4896861, 60453
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Address
Advocate Children's Hospital-Park Ridge
Park Ridge 4905367, Illinois 4896861, 60068
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Address
Saint Jude Midwest Affiliate
Peoria 4905687, Illinois 4896861, 61637
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Address
Blank Children's Hospital
Des Moines 4853828, Iowa 4862182, 50309
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Address
University of Iowa/Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182, 52242
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Address
University of Kentucky/Markey Cancer Center
Lexington 4297983, Kentucky 6254925, 40536
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Address
Norton Children's Hospital
Louisville 4299276, Kentucky 6254925, 40202
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Address
Children's Hospital New Orleans
New Orleans 4335045, Louisiana 4331987, 70118
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Sinai Hospital of Baltimore
Baltimore 4347778, Maryland 4361885, 21215
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Address
Massachusetts General Hospital Cancer Center
Boston 4930956, Massachusetts 6254926, 02114
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Address
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
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Address
Baystate Medical Center
Springfield 4951788, Massachusetts 6254926, 01199
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Address
C S Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836, 48109
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Address
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis 5037649, Minnesota 5037779, 55404
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University of Minnesota/Masonic Cancer Center
Minneapolis 5037649, Minnesota 5037779, 55455
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Address
University of Mississippi Medical Center
Jackson 4431410, Mississippi 4436296, 39216
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Address
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678, 64108
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Cardinal Glennon Children's Medical Center
St Louis 4407066, Missouri 4398678, 63104
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Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
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Address
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760, 07601
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Address
Saint Joseph's Regional Medical Center
Paterson 5102466, New Jersey 5101760, 07503
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Address
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, 14263
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Address
Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638, 11794
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Address
UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348, 27599
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Address
Carolinas Medical Center/Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348, 28203
Status
Address
Duke University Medical Center
Durham 4464368, North Carolina 4482348, 27710
Status
Address
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348, 27157
Status
Address
Children's Hospital Medical Center of Akron
Akron 5145476, Ohio 5165418, 44308
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Address
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, 45229
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Address
Rainbow Babies and Childrens Hospital
Cleveland 5150529, Ohio 5165418, 44106
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Address
Nationwide Children's Hospital
Columbus 4509177, Ohio 5165418, 43205
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Address
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379, 73104
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Address
Legacy Emanuel Children's Hospital
Portland 5746545, Oregon 5744337, 97227
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Address
Oregon Health and Science University
Portland 5746545, Oregon 5744337, 97239
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Address
Penn State Children's Hospital
Hershey 5193342, Pennsylvania 6254927, 17033
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Address
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
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Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927, 15224
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Address
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040, 29425
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Address
BI-LO Charities Children's Cancer Center
Greenville 4580543, South Carolina 4597040, 29605
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Address
Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223, 57117-5134
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Address
East Tennessee Childrens Hospital
Knoxville 4634946, Tennessee 4662168, 37916
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Address
Saint Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168, 38105
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Address
Vanderbilt University/Ingram Cancer Center
Nashville 4644585, Tennessee 4662168, 37232
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Address
Dell Children's Medical Center of Central Texas
Austin 4671654, Texas 4736286, 78723
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Address
Medical City Dallas Hospital
Dallas 4684888, Texas 4736286, 75230
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Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286, 75390
Status
Address
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286, 76104
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Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston 4699066, Texas 4736286, 77030
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Address
Methodist Children's Hospital of South Texas
San Antonio 4726206, Texas 4736286, 78229
Status
Address
University of Texas Health Science Center at San Antonio
San Antonio 4726206, Texas 4736286, 78229
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Address
Naval Medical Center - Portsmouth
Portsmouth 4779999, Virginia 6254928, 23708-2197
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Address
Virginia Commonwealth University/Massey Cancer Center
Richmond 4781708, Virginia 6254928, 23298
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Address
Seattle Children's Hospital
Seattle 5809844, Washington 5815135, 98105
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Address
Providence Sacred Heart Medical Center and Children's Hospital
Spokane 5811696, Washington 5815135, 99204
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University of Wisconsin Carbone Cancer Center
Madison 5261457, Wisconsin 5279468, 53792
International Sites
Status
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Princess Margaret Hospital for Children
Perth 2063523, Western Australia 2058645, 6008
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Perth Children's Hospital
Perth 2063523, Western Australia 2058645, 6009
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Alberta Children's Hospital
Calgary 5913490, Alberta 5883102, T3B 6A8
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Address
University of Alberta Hospital
Edmonton 5946768, Alberta 5883102, T6G 2B7
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Address
CancerCare Manitoba
Winnipeg 6183235, Manitoba 6065171, R3E 0V9
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Address
IWK Health Centre
Halifax 6324729, Nova Scotia 6091530, B3K 6R8
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Address
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton 5969782, Ontario 6093943, L8N 3Z5
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Address
Kingston Health Sciences Centre
Kingston 5992500, Ontario 6093943, K7L 2V7
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Address
Children's Hospital of Eastern Ontario
Ottawa 6094817, Ontario 6093943, K1H 8L1
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Address
Hospital for Sick Children
Toronto 6167865, Ontario 6093943, M5G 1X8
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Address
The Montreal Children's Hospital of the MUHC
Montreal 6077243, Quebec 6115047, H3H 1P3
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Address
Centre Hospitalier Universitaire Sainte-Justine
Montreal 6077243, Quebec 6115047, H3T 1C5
Status
Address
Centre Hospitalier Universitaire de Quebec
Québec 6325494, , G1V 4G2
Status
Address
Starship Children's Hospital
Grafton 6232401, Auckland 2193734, 1145
