Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
Ganglioneuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma
About this trial
This is an observational trial for Ganglioneuroblastoma
Eligibility Criteria
Inclusion Criteria:
All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's Oncology Group (COG) institutions are eligible for this study
- There will be no penalty under any circumstances for enrollment of a patient whose definitive institutional diagnosis, or central review diagnosis, is found to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/ maturing subtype
Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and procurement of study-related tissues with the following exception:
- Patients that in the opinion of the treating physician are too ill to undergo pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on ANBL00B1; documentation of the emergent nature of therapy initiation is required
- It is required that a good faith effort (documented by specimen tracking) be made to submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow) of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be obtained prior to initiation of therapy
Exceptions
In rare cases, patients may be deemed too ill to undergo pre-treatment tissue biopsy and require EMERGENT therapy; the following eligibility guidelines apply to these cases:
- For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g., primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT therapy initiation should be made; however, if the child is deemed too unstable for such a procedure they may still be enrolled as long as pre-treatment peripheral blood and serum have been submitted
For all other INSS stages: tumor tissue should be obtained as soon as possible within 96 hours of EMERGENT therapy initiation; patients without tumor tissues submitted within this time-frame are not eligible for enrollment
- Note: it may not be possible to obtain all necessary tumor biomarkers for therapy stratification in such cases; if a patient enrolled on ANBL00B1 undergoes an additional diagnostic procedure within 96 hours of initiating therapy, additional tumor specimens may be submitted to obtain biomarkers used for risk classification; the decision to perform such procedures, and/or submit these specimens, is to be made by the managing clinicians and should reflect the clinical need to know the status of such biomarkers
- Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a tumor biopsy or resection upfront; tumor tissue submission is therefore not required for these patients to enroll on ANBL00B1; a peripheral blood and serum sample is the only specimen required to be submitted for this group of patients; should they undergo a biopsy or resection at a later date tumor can be submitted for biomarker testing at this time
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1 protocol
Sites / Locations
- Children's Hospital of AlabamaRecruiting
- University of Alabama at Birmingham Cancer Center
- USA Health Strada Patient Care CenterRecruiting
- Providence Alaska Medical CenterRecruiting
- Cardon Children's Medical CenterRecruiting
- Phoenix Childrens HospitalRecruiting
- The University of Arizona Medical Center-University CampusRecruiting
- Arkansas Children's HospitalRecruiting
- University of Arkansas for Medical Sciences
- Kaiser Permanente Downey Medical CenterRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Loma Linda University Medical CenterRecruiting
- Miller Children's and Women's Hospital Long BeachRecruiting
- Children's Hospital Los AngelesRecruiting
- Cedars Sinai Medical CenterRecruiting
- Mattel Children's Hospital UCLARecruiting
- Valley Children's HospitalRecruiting
- Children's Hospital and Research Center at OaklandRecruiting
- Kaiser Permanente-OaklandRecruiting
- Children's Hospital of Orange CountyRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Lucile Packard Children's Hospital Stanford UniversityRecruiting
- Sutter Medical Center SacramentoRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Rady Children's Hospital - San DiegoRecruiting
- Naval Medical Center -San DiegoRecruiting
- UCSF Medical Center-Parnassus
- UCSF Medical Center-Mission BayRecruiting
- Santa Barbara Cottage HospitalRecruiting
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical CenterRecruiting
- Children's Hospital ColoradoRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical CenterRecruiting
- Connecticut Children's Medical CenterRecruiting
- Yale UniversityRecruiting
- Alfred I duPont Hospital for ChildrenRecruiting
- MedStar Georgetown University HospitalRecruiting
- Children's National Medical CenterRecruiting
- Broward Health Medical CenterRecruiting
- Lee Memorial Health System
- Golisano Children's Hospital of Southwest FloridaRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Memorial Regional Hospital/Joe DiMaggio Children's HospitalRecruiting
- Nemours Children's Clinic-JacksonvilleRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
- Nicklaus Children's HospitalRecruiting
- Miami Cancer InstituteRecruiting
- Florida Hospital OrlandoRecruiting
- Arnold Palmer Hospital for ChildrenRecruiting
- Nemours Children's Clinic - Orlando
- UF Cancer Center at Orlando Health
- Nemours Children's HospitalRecruiting
- Nemours Children's Clinic - Pensacola
- Johns Hopkins All Children's HospitalRecruiting
- Tampa General HospitalRecruiting
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Mary's HospitalRecruiting
- Children's Healthcare of Atlanta - EglestonRecruiting
- Augusta University Medical CenterRecruiting
- Memorial Health University Medical CenterRecruiting
- University of Hawaii Cancer Center
- Kapiolani Medical Center for Women and ChildrenRecruiting
- Tripler Army Medical Center
- Saint Luke's Mountain States Tumor InstituteRecruiting
- Lurie Children's Hospital-ChicagoRecruiting
- Rush University Medical CenterRecruiting
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Loyola University Medical Center
- Advocate Children's Hospital-Oak LawnRecruiting
- Advocate Children's Hospital-Park RidgeRecruiting
- Advocate Lutheran General Hospital
- Saint Jude Midwest AffiliateRecruiting
- Southern Illinois University School of MedicineRecruiting
- Riley Hospital for ChildrenRecruiting
- Saint Vincent Hospital and Health Care Center
- Blank Children's HospitalRecruiting
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Norton Children's HospitalRecruiting
- Tulane University Health Sciences Center
- Children's Hospital New OrleansRecruiting
- Ochsner Medical Center JeffersonRecruiting
- Eastern Maine Medical CenterRecruiting
- Maine Children's Cancer ProgramRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Sinai Hospital of BaltimoreRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Walter Reed National Military Medical CenterRecruiting
- Floating Hospital for Children at Tufts Medical CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Baystate Medical CenterRecruiting
- University of Massachusetts Medical School
- C S Mott Children's HospitalRecruiting
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Michigan State University Clinical CenterRecruiting
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum HealthRecruiting
- Bronson Methodist HospitalRecruiting
- Kalamazoo Center for Medical Studies
- Beaumont Children's Hospital-Royal OakRecruiting
- William Beaumont Hospital-Royal Oak
- Children's Hospitals and Clinics of Minnesota - MinneapolisRecruiting
- University of Minnesota/Masonic Cancer CenterRecruiting
- Mayo ClinicRecruiting
- University of Mississippi Medical CenterRecruiting
- Columbia RegionalRecruiting
- Children's Mercy Hospitals and ClinicsRecruiting
- Cardinal Glennon Children's Medical CenterRecruiting
- Washington University School of MedicineRecruiting
- Mercy Hospital Saint LouisRecruiting
- Children's Hospital and Medical Center of OmahaRecruiting
- University of Nebraska Medical CenterRecruiting
- University Medical Center of Southern NevadaRecruiting
- Sunrise Hospital and Medical CenterRecruiting
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationRecruiting
- Summerlin Hospital Medical CenterRecruiting
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical CenterRecruiting
- Saint Barnabas Medical Center
- Morristown Medical CenterRecruiting
- Saint Peter's University HospitalRecruiting
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University HospitalRecruiting
- Newark Beth Israel Medical CenterRecruiting
- Saint Joseph's Regional Medical Center
- Overlook Hospital
- University of New Mexico Cancer CenterRecruiting
- Albany Medical CenterRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Brooklyn Hospital Center
- State University of New York Downstate Medical CenterRecruiting
- Maimonides Medical CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- NYU Winthrop HospitalRecruiting
- The Steven and Alexandra Cohen Children's Medical Center of New YorkRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Mount Sinai HospitalRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- University of RochesterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- New York Medical CollegeRecruiting
- Mission Hospital Inc-Memorial CampusRecruiting
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Duke University Medical CenterRecruiting
- East Carolina UniversityRecruiting
- Wake Forest University Health SciencesRecruiting
- Sanford Broadway Medical CenterRecruiting
- Children's Hospital Medical Center of AkronRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Rainbow Babies and Childrens HospitalRecruiting
- Cleveland Clinic Foundation
- Nationwide Children's HospitalRecruiting
- Dayton Children's HospitalRecruiting
- The Toledo Hospital/Toledo Children's HospitalRecruiting
- Mercy Children's Hospital
- Tod Children's Hospital - Forum HealthRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Natalie Warren Bryant Cancer Center at Saint FrancisRecruiting
- Legacy Emanuel Children's HospitalRecruiting
- Legacy Emanuel Hospital and Health Center
- Oregon Health and Science UniversityRecruiting
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Medical CenterRecruiting
- Penn State Children's Hospital
- Children's Hospital of PhiladelphiaRecruiting
- Saint Christopher's Hospital for ChildrenRecruiting
- Children's Hospital of Pittsburgh of UPMCRecruiting
- Rhode Island HospitalRecruiting
- Medical University of South CarolinaRecruiting
- Prisma Health Richland HospitalRecruiting
- BI-LO Charities Children's Cancer CenterRecruiting
- Greenville Cancer Treatment Center
- Sanford USD Medical Center - Sioux FallsRecruiting
- T C Thompson Children's HospitalRecruiting
- East Tennessee State UniversityRecruiting
- East Tennessee Childrens HospitalRecruiting
- St. Jude Children's Research HospitalRecruiting
- The Children's Hospital at TriStar CentennialRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- Texas Tech University Health Sciences Center-Amarillo
- Dell Children's Medical Center of Central TexasRecruiting
- Driscoll Children's HospitalRecruiting
- Medical City Dallas HospitalRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- El Paso Children's HospitalRecruiting
- Brooke Army Medical Center
- Cook Children's Medical CenterRecruiting
- University of Texas Medical BranchRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- M D Anderson Cancer CenterRecruiting
- Covenant Children's HospitalRecruiting
- Children's Hospital of San AntonioRecruiting
- Methodist Children's Hospital of South TexasRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Scott and White Memorial HospitalRecruiting
- Primary Children's HospitalRecruiting
- University of Vermont and State Agricultural CollegeRecruiting
- University of Virginia Cancer CenterRecruiting
- Inova Fairfax HospitalRecruiting
- Children's Hospital of The King's DaughtersRecruiting
- Naval Medical Center - Portsmouth
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Carilion Clinic Children's HospitalRecruiting
- Seattle Children's HospitalRecruiting
- Kaiser Permanente WashingtonRecruiting
- Providence Sacred Heart Medical Center and Children's HospitalRecruiting
- Mary Bridge Children's Hospital and Health CenterRecruiting
- Madigan Army Medical CenterRecruiting
- West Virginia University Charleston DivisionRecruiting
- West Virginia University HealthcareRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- University of Wisconsin Hospital and ClinicsRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Children's Hospital of WisconsinRecruiting
- John Hunter Children's HospitalRecruiting
- Sydney Children's HospitalRecruiting
- The Children's Hospital at WestmeadRecruiting
- Royal Brisbane and Women's Hospital
- Royal Children's Hospital-Brisbane
- Queensland Children's HospitalRecruiting
- Women's and Children's Hospital-AdelaideRecruiting
- Royal Children's HospitalRecruiting
- Princess Margaret Hospital for Children
- Perth Children's HospitalRecruiting
- Alberta Children's HospitalRecruiting
- University of Alberta HospitalRecruiting
- British Columbia Children's HospitalRecruiting
- CancerCare ManitobaRecruiting
- Janeway Child Health CentreRecruiting
- IWK Health CentreRecruiting
- McMaster Children's Hospital at Hamilton Health SciencesRecruiting
- Kingston Health Sciences CentreRecruiting
- Children's HospitalRecruiting
- Children's Hospital of Eastern OntarioRecruiting
- Hospital for Sick ChildrenRecruiting
- The Montreal Children's Hospital of the MUHCRecruiting
- Centre Hospitalier Universitaire Sainte-JustineRecruiting
- Allan Blair Cancer Centre
- Saskatoon Cancer CentreRecruiting
- Centre Hospitalier Universitaire de QuebecRecruiting
- University Medical Center GroningenRecruiting
- Starship Children's HospitalRecruiting
- Christchurch HospitalRecruiting
- HIMA San Pablo Oncologic HospitalRecruiting
- San Jorge Children's HospitalRecruiting
- University Pediatric HospitalRecruiting
- King Faisal Specialist Hospital and Research Centre
- Swiss Pediatric Oncology Group - Bern
- Swiss Pediatric Oncology Group - Geneva
- Swiss Pediatric Oncology Group - Lausanne
Arms of the Study
Arm 1
Ancillary-Correlative (cytology specimen collection)
Patients undergo collection of blood, tissue, and bone marrow samples for analysis via RT-PCR, quantitative PCR, flow cytometry, and FISH.