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

Neuroblastoma Clinical Trial

— PHRCNB07  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864563
• Other study ID #: IC 2007-09
• Status: Completed
• Phase: N/A
• Start date: October 4, 2008
• Est. completion date: July 2023

Study information

• Verified date: November 2023
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: July 2023
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Nord Amiens	Amiens
France	Chu Angers	Angers
France	Chr R.Pellegrin	Bordeaux
France	CHU MORVAN Brest	Brest
France	CHR CAEN	Caen
France	Chu Bocage	Dijon
France	Chu Grenoble	Grenoble
France	Chu Lille	Lille
France	Hopital de La Mere Et de L'Enfant Limoges	Limoges
France	Centre Leon Berard	Lyon
France	Hopital D'Enfants de La Timone	Marseille
France	Hopital Arnaud de Villeneuve	Montpellier
France	CHR MONCOUSU Nantes	Nantes
France	CHU Nice Hôpital L'Archet 2	Nice
France	Hôpital Armand TROUSSEAU	Paris
France	Institut Curie	Paris
France	Hôpital Jean Bernard de la Milétrie	Poitiers
France	Höpital Americain Reims	Reims
France	CHR Hôpital Sud Rennes	Rennes
France	Hôpital Charles Nicolle ROUEN	Rouen
France	Chr Felix Guyon	Saint Denis
France	CHU SAINT-ETIENNE Hôpital Nord	Saint-priest En Jarez
France	Hôpital Hautepierre Strasbourg	Strasbourg
France	Hôpital des Enfants Toulouse	Toulouse
France	CHU TOURS Hôpital Clocheville	Tours
France	Hopital Des Enfants Nancy	Vandoeuvre Les Nancy
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Overall-Free survival	Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.	3 years