Clinical trial NCT02864563: Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
Official title: Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroblastoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 560
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free survival
timeFrame: 3 years
Secondary outcomes:
measure: Progression at metastatic location-Free survival
timeFrame: 3 years
measure: Overall-Free survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Hôpital Nord Amiens
city: Angers
country: France
facility: Chu Angers
city: Bordeaux
country: France
facility: Chr R.Pellegrin
city: Brest
country: France
facility: CHU MORVAN Brest
city: Caen
country: France
facility: CHR CAEN
city: Dijon
country: France
facility: Chu Bocage
city: Grenoble
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: Chu Lille
city: Limoges
country: France
facility: Hopital de La Mere Et de L'Enfant Limoges
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Hopital D'Enfants de La Timone
city: Montpellier
country: France
facility: Hopital Arnaud de Villeneuve
city: Nantes
country: France
facility: CHR MONCOUSU Nantes
city: Nice
country: France
facility: CHU Nice Hôpital L'Archet 2
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Armand TROUSSEAU
city: Poitiers
country: France
facility: Hôpital Jean Bernard de la Milétrie
city: Reims
country: France
facility: Höpital Americain Reims
city: Rennes
country: France
facility: CHR Hôpital Sud Rennes
city: Rouen
country: France
facility: Hôpital Charles Nicolle ROUEN
city: Saint Denis
country: France
facility: Chr Felix Guyon
city: Saint-priest En Jarez
country: France
facility: CHU SAINT-ETIENNE Hôpital Nord
city: Strasbourg
country: France
facility: Hôpital Hautepierre Strasbourg
city: Toulouse
country: France
facility: Hôpital des Enfants Toulouse
city: Tours
country: France
facility: CHU TOURS Hôpital Clocheville
city: Vandoeuvre Les Nancy
country: France
facility: Hopital Des Enfants Nancy
city: Villejuif
country: France
facility: Gustave Roussy
Study officials:
affiliation: Institut Curie
name: Gudrun Shleiermacher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: