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

Not Applicable

Completed

• Conditions: Neuroblastoma
• Interventions: Procedure: Blood sampling

• Registration Number: NCT02864563
• Lead Sponsor: Institut Curie

Brief 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.

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 Timeline

• Study Start: 2008-10-04
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-12
• Primary Completion: 2022-07-28
• Study Completion: 2023-07
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 560

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Blood sampling	Experimental arm, prospective cohort

Primary Outcome Measures

Name	Time	Method
Progression-Free survival	3 years	Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.

Secondary Outcome Measures

Name	Time	Method
Progression at metastatic location-Free survival	3 years	Time between patient diagnosis and progression/ relapse at metastatic location or death.; Correlation with the genomic profile established by CGH-array.
Overall-Free survival	3 years	Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.

Trial Locations

Locations (27)

CHU MORVAN Brest; 🇫🇷 Brest, France

Hôpital Nord Amiens; 🇫🇷 Amiens, France

Chu Angers; 🇫🇷 Angers, France

CHR CAEN; 🇫🇷 Caen, France

Chu Lille; 🇫🇷 Lille, France

Hôpital Jean Bernard de la Milétrie; 🇫🇷 Poitiers, France

Gustave Roussy; 🇫🇷 Villejuif, France

Hopital de La Mere Et de L'Enfant Limoges; 🇫🇷 Limoges, France

Hôpital Armand TROUSSEAU; 🇫🇷 Paris, France

Chu Bocage; 🇫🇷 Dijon, France

Hôpital des Enfants Toulouse; 🇫🇷 Toulouse, France

Chu Grenoble; 🇫🇷 Grenoble, France

Hopital D'Enfants de La Timone; 🇫🇷 Marseille, France

Hopital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHR Hôpital Sud Rennes; 🇫🇷 Rennes, France

Hôpital Hautepierre Strasbourg; 🇫🇷 Strasbourg, France

CHU Nice Hôpital L'Archet 2; 🇫🇷 Nice, France

Chr Felix Guyon; 🇫🇷 Saint Denis, France

CHU SAINT-ETIENNE Hôpital Nord; 🇫🇷 Saint-priest En Jarez, France

CHU TOURS Hôpital Clocheville; 🇫🇷 Tours, France

Hopital Des Enfants Nancy; 🇫🇷 Vandoeuvre Les Nancy, France

Institut Curie; 🇫🇷 Paris, France

Höpital Americain Reims; 🇫🇷 Reims, France

Hôpital Charles Nicolle ROUEN; 🇫🇷 Rouen, France

Chr R.Pellegrin; 🇫🇷 Bordeaux, France

Centre Leon Berard; 🇫🇷 Lyon, France

CHR MONCOUSU Nantes; 🇫🇷 Nantes, France