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

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.

Study Overview

• Status: Completed
• Conditions: Neuroblastoma
• Intervention / Treatment: Procedure: Blood sampling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Hôpital Nord Amiens
  • Angers, France, 49033
    • Chu Angers
  • Bordeaux, France, 25030
    • Chr R.Pellegrin
  • Brest, France, 29609
    • CHU Morvan Brest
  • Caen, France, 14033
    • CHR CAEN
  • Dijon, France, 21079
    • CHU Bocage
  • Grenoble, France, 38045
    • CHU Grenoble
  • Lille, France, 59020
    • Chu Lille
  • Limoges, France, 87042
    • Hopital de La Mere Et de L'Enfant Limoges
  • Lyon, France, 69373
    • Centre Leon Berard
  • Marseille, France, 13385
    • Hôpital d'Enfants de la Timone
  • Montpellier, France, 34059
    • Hôpital Arnaud de Villeneuve
  • Nantes, France, 44035
    • CHR MONCOUSU Nantes
  • Nice, France, 06202
    • CHU Nice Hôpital L'Archet 2
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75571
    • Hopital Armand Trousseau
  • Poitiers, France, 86021
    • Hôpital Jean Bernard de la Milétrie
  • Reims, France, 51092
    • Höpital Americain Reims
  • Rennes, France, 35056
    • CHR Hôpital Sud Rennes
  • Rouen, France, 76031
    • Hôpital Charles Nicolle Rouen
  • Saint Denis, France, 97405
    • Chr Felix Guyon
  • Saint-priest En Jarez, France, 42270
    • CHU Saint-Etienne Hôpital NOrd
  • Strasbourg, France, 67098
    • Hôpital Hautepierre Strasbourg
  • Toulouse, France, 31026
    • Hôpital des Enfants Toulouse
  • Tours, France, 37044
    • CHU Tours Hôpital Clocheville
  • Vandoeuvre Les Nancy, France, 54500
    • Hopital Des Enfants Nancy
  • Villejuif, France, 94805
    • Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

7. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prospective cohort; Experimental arm, prospective cohort	Procedure: Blood sampling; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Gudrun Shleiermacher, MD, PhD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2008
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimated): August 12, 2016

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma
• Other Study ID Numbers: IC 2007-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will share de-identified data sets with interested researchers, educators or clinicians. Materials generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).