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

Inclusion Criteria:

• All newly diagnosed patients with suspected neuroblastoma, suspectedganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen atChildren's Oncology Group (COG) institutions are eligible for this study

• There will be no penalty under any circumstances for enrollment of a patientwhose definitive institutional diagnosis, or central review diagnosis, is foundto be a tumor other than neuroblastoma, ganglioneuroblastoma, organglioneuroma/ maturing subtype

• Patients may not have received chemotherapy prior to enrollment on ANBL00B1 andprocurement of study-related tissues with the following exception:

• Patients that in the opinion of the treating physician are too ill to undergopre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolledon ANBL00B1; documentation of the emergent nature of therapy initiation isrequired

• It is required that a good faith effort (documented by specimen tracking) be made tosubmit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow)of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory inorder for any newly diagnosed patient to be enrolled on ANBL00B1; this should beobtained prior to initiation of therapy

• Exceptions

• In rare cases, patients may be deemed too ill to undergo pre-treatment tissuebiopsy and require EMERGENT therapy; the following eligibility guidelines applyto 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 ofEMERGENT therapy initiation should be made; however, if the child isdeemed too unstable for such a procedure they may still be enrolled aslong as pre-treatment peripheral blood and serum have been submitted

• For all other INSS stages: tumor tissue should be obtained as soon aspossible within 96 hours of EMERGENT therapy initiation; patients withouttumor tissues submitted within this time-frame are not eligible forenrollment

• Note: it may not be possible to obtain all necessary tumor biomarkersfor therapy stratification in such cases; if a patient enrolled onANBL00B1 undergoes an additional diagnostic procedure within 96 hoursof initiating therapy, additional tumor specimens may be submitted toobtain biomarkers used for risk classification; the decision toperform such procedures, and/or submit these specimens, is to be madeby the managing clinicians and should reflect the clinical need toknow the status of such biomarkers

• Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have atumor biopsy or resection upfront; tumor tissue submission is thereforenot required for these patients to enroll on ANBL00B1; a peripheral bloodand serum sample is the only specimen required to be submitted for thisgroup of patients; should they undergo a biopsy or resection at a laterdate tumor can be submitted for biomarker testing at this time

• All patients and/or their parents or legal guardians must sign a written informedconsent

• 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 originaldiagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1protocol