ANBL00B1: Neuroblastoma Biology Studies
To collect tissue, bone marrow and peripheral blood samples of patients with neuroblastoma for immediate use to measure tumor expression patterns and to deposit in a repository for long-term storage. Samples will be collected at the time of initial diagnosis or at the time of the therapeutic surgical procedure, as clinically indicated. These samples will be obtained when other samples are obtained for standard care. These samples can be used for approved projects by laboratory-based investigators.
1. All newly diagnosed patients with suspected neuroblastoma, suspected ganglioneuroblastoma, or suspected ganglioneuroma (maturing subtype) are eligible. 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.
2. 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. Please see the appropriate open COG
therapeutic trial for further study-specific eligibility regarding EMERGENT therapy. Documentation of the emergent nature of therapy initiation is required. See Section 4.2.3 for required specimens in such cases.
3. 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. 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 as described in Sections 5.1.3 and 5.1.4. 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.
4. All patients and/or their parents or legal guardians must sign a written informed consent.
5. All institutional, FDA, and NCI requirements for human studies must be met.
6. Spanish-speaking subjects are eligible for study participation.
7. 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.