Study of DNA in Blood Samples From Patients With Neuroblastoma

Study Overview
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Brief Summary
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This research trial studies is deoxyribonucleic acid (DNA) in blood samples from patients with neuroblastoma. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed Description
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OBJECTIVES: I. Perform in a blind study a multicentric study by analyzing serum from patients at diagnosis (with a known tumor v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) status determined in the Children's Oncology Group [COG] reference lab), in order to confirm our previous data and to define the most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases. II. Define the limits of the procedure in non-metastatic patients and in those with reduced tumor burden (International Neuroblastoma Staging System [INSS] stage 1 and 2). OUTLINE: Circulating DNA is extracted from serum. Polymerase chain reaction (PCR) amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed.

Official Title
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Analysis of Circulating MYCN DNA in Serum Samples Obtained From Patients With Neuroblastoma

Conditions
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Disseminated Neuroblastoma, Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4S Neuroblastoma

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Genetic: polymerase chain reaction
* Genetic: polyacrylamide gel electrophoresis
* Genetic: DNA analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum samples from neuroblastoma (NB) patients obtained through the COG (and legacy Children's Cancer Group [CCG]/Pediatric Oncology Group [POG] Biology Studies) The MYCN status on corresponding tumors have been determined using standard techniques; the panel of samples must be obtained from NB patients with and without MYCN amplification tumors Cases will be drawn from clinical subsets at greatest likelihood to benefit from this testing ability, stage 1 and 2 NBs (both infants and toddlers), stage 4 patients under 18 months of age, and 4S patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative<br>Circulating DNA is extracted from serum. PCR amplification of MYCN is performed and analyzed by agarose gel electrophoresis. Real-time quantitative PCR is also performed. | Other: laboratory biomarker analysis<br>* Correlative studies<br>Genetic: polymerase chain reaction<br>* Correlative studies<br>* Other names: PCR;Genetic: polyacrylamide gel electrophoresis<br>* Correlative studies<br>* Other names: electrophoresis, polyacrylamide gel;Genetic: DNA analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most appropriate MYCN/control ratio cutoff capable of determining positive and negative cases of neuroblastoma assessed by PCR |  | Up to 6 months | 
| Limits of the procedure in non-metastatic patients and in those with reduced tumor burden |  | Up to 6 months |