Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification (PHRCNB07)

Institut Curie

Status: Completed

Conditions: Neuroblastoma

Treatments: Procedure: Blood sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT02864563

IC 2007-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 560 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Neuroblastoma or Ganglioneuroblastoma defined by INSS criteria (Brodeur et al. 1993)

2. Age < 18 years

3. Availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60%

4. Inclusion in 4 months following the diagnosis

5. All patients treated in French centers (SFCE) for Neuroblastic tumour, including those participate in national or international protocols.

6. Written informed consent 8. Patients with French Social Security in compliance with the French law relating to biomedical research.

Exclusion criteria

1. Chemotherapy or radiotherapy before taking tumour samples
2. Refusal of the parents or the legal representatives

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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560 participants in 1 patient group

Prospective cohort

Experimental group

Description:

Experimental arm, prospective cohort

Treatment:

Procedure: Blood sampling