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

• 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

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
Overall-Free survival	3 years	Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.
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.

Trial Locations

Locations (27)

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

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