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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00170 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ALTE15N2 | Other Identifier | Children's Oncology Group | |
| COG-ALTE15N2 | Other Identifier | DCP | |
| ALTE15N2 | Other Identifier | CTEP | |
| UG1CA189955 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytology Specimen Collection Procedure | Other | Undergo collection of blood and urine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of specific late effects | Late effects of interest are organ dysfunction, subsequent malignant neoplasms (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction. Prevalence will be calculated as the number of patients with late effects divided by the number with known status of that endpoint. | Up to 3 years |
| Risk factors of late effects | Risk factors of interest include sex, race, ethnicity, current age, length of follow up, MYCN status, stage, primary site, age at diagnosis, total anthracycline dose (doxorubicin equivalents), cyclophosphamide dose equivalent categories, total platinum exposure (dose), topotecan exposure (yes [Y]/no [N]), cis-retinoic acid exposure (Y/N), GD-2/cytokine exposure (Y/N), radiation (Y/N), abdominal RT (Y/N), radiation to metastatic sites (Y/N), number of transplants, number of meta-iodobenzylguanidine (MIBG) scans, and therapeutic MIBG (Y/N). Will be reported as the number of patients with the risk factor divided by the number with known status of that risk factor for categorical variables and descriptively (mean, standard deviation) for continuous variables. | Up to 3 years |
| Pediatric Quality of Life (PedsQL) score | PedsQL score will be reported descriptively (mean, standard deviation). The proportion of patients with impaired physical growth, delayed pubertal development, chronic disease, impaired executive functioning, and impaired social functioning will also be reported. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Collection and storage of blood samples | Proportion of survivors and their families that consent for future utilization of their banked sample for future research will be reported. | Up to 3 years |
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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
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
Patients with current active neuroblastoma relapse are ineligible
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Patients enrolled on Children's Oncology Group (COG) study ANBL00B1 diagnosed with high-risk neuroblastoma
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| Name | Affiliation | Role |
|---|---|---|
| Tara O Henderson | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Phoenix Childrens Hospital |
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Blood, urine
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | United States |
| UCSF Medical Center-Mission Bay | San Francisco | California | 94158 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia | 30322 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Children's Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Naval Medical Center - Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6008 | Australia |
| Perth Children's Hospital | Perth | Western Australia | 6009 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H3H 1P3 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1V 4G2 | Canada |
| Starship Children's Hospital | Grafton | Auckland | 1145 | New Zealand |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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