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Analyzing tumor biomarkers in newly diagnosed neuroblastoma patients

Neuroblastoma Biology Studies

Observational Children's Oncology Group · NCT00904241

This study is testing if certain markers in tumor samples from newly diagnosed neuroblastoma patients can help doctors understand the risk level and predict how well treatments might work.

Quick facts

Study typeObservational
Enrollment10000 (estimated)
AgesN/A to 30 Years
SexAll
SponsorChildren's Oncology Group Research network
Drugs / interventionschemotherapy
Locations259 sites (Birmingham, Alabama and 258 other locations)
Trial IDNCT00904241 on ClinicalTrials.gov

What this trial studies

This research focuses on studying biomarkers in tumor tissue samples from patients newly diagnosed with neuroblastoma or ganglioneuroblastoma. The study aims to analyze various factors used for risk-group assignment, including MYCN copy number and tumor histology, at the time of diagnosis. Additionally, it will maintain a reference bank of clinically and genetically characterized tumor samples for future research. The study also seeks to evaluate the genetic status of specific alleles and the expression of neurotrophin-related genes to predict treatment response and outcomes.

Who should consider this trial

Good fit: Ideal candidates include newly diagnosed patients with suspected neuroblastoma or ganglioneuroblastoma who are seen at Children's Oncology Group institutions.

Not a fit: Patients who have already received chemotherapy prior to enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of neuroblastoma and improve risk stratification and treatment strategies for patients.

How similar studies have performed: Other studies analyzing biomarkers in neuroblastoma have shown promise, suggesting that this approach could yield valuable insights.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 258 other locations

+209 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions GanglioneuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRegional NeuroblastomaStage 4 NeuroblastomaStage 4S Neuroblastoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.