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NCT Number: NCT02864563

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

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.

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Key information

Conditions

Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Nord Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

blood sampling

Procedure
  • 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.

Primary outcomes

  1. Progression-Free survival

    Time frame: 3 years

    Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.

Secondary outcomes

  1. Progression at metastatic location-Free survival

    Time frame: 3 years

    Time between patient diagnosis and progression/ relapse at metastatic location or death.

    Correlation with the genomic profile established by CGH-array.

  2. Overall-Free survival

    Time frame: 3 years

    Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: PHRCNB07

Important dates

Study start
2008
Primary completion
2022
Study completion
2023
First posted
Aug 12, 2016
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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