Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification

Study Overview
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Brief Summary
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Neuroblastoma (NB) is characterized by its wide heterogeneity in clinical presentation and evolution. Recent retrospective studies have revealed by CGH-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification. This protocol deals with a prospective analysis of the genomic profile established by CGH-array on the tumor samples obtained at the diagnosis of all the patients with NB in France, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. The objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment.

Detailed Description
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After diagnosis of Neuroblastoma (NB) or Ganglioneuroblastoma : Frozen tumor sample (cell content ≥60%) must be sent for genomic profile determination by CGH-array, Blood sample at diagnosis must be sent to evaluate MYCN amplification in plasma, In case of NB with a MYCN amplification, blood sample during treatment and follow-up must be sent.

Official Title
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Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification

Conditions
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Neuroblastoma

Intervention / Treatment
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* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neuroblastoma or Ganglioneuroblastoma defined by INSS criteria (Brodeur et al. 1993) Age < 18 years Availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60% Inclusion in 4 months following the diagnosis All patients treated in French centers (SFCE) for Neuroblastic tumour, including those participate in national or international protocols. 7. Written informed consent 8. Patients with French Social Security in compliance with the French law relating to biomedical research. Exclusion Criteria: Chemotherapy or radiotherapy before taking tumour samples Refusal of the parents or the legal representatives

Ages Eligible for Study
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Maximum Age: 18 Years

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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective cohort<br>Experimental arm, prospective cohort | Procedure: Blood sampling<br>* Blood sample at diagnosis to evaluate MYCN amplification in plasma. In case of NB with a MYCN amplification, blood samples are also collected during treatment and follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free survival | Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression at metastatic location-Free survival | Time between patient diagnosis and progression/ relapse at metastatic location or death. Correlation with the genomic profile established by CGH-array. | 3 years | 
| Overall-Free survival | Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array. | 3 years |