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


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Trial ID: NCT00904241,29,26500,45600


This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Official Title

Neuroblastoma Biology Studies

Stanford Investigator(s)


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

            - 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

   - 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


other: cytology specimen collection procedure

other: laboratory biomarker analysis


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Richard Fu

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