Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

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