Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
PHRCNB07
1 other identifier
interventional
560
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2008
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedDecember 1, 2023
November 1, 2023
13.8 years
August 9, 2016
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Progression at metastatic location-Free survival
3 years
Overall-Free survival
3 years
Study Arms (1)
Prospective cohort
EXPERIMENTALExperimental arm, prospective cohort
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Neuroblastoma or Ganglioneuroblastoma defined by INSS criteria (Brodeur et al. 1993)
- Age \< 18 years
- Availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60%
- All patients treated in French centers (SFCE) for Neuroblastic tumour, including those participate in national or international protocols.
- \. Written informed consent 8. Patients with French Social Security in compliance with the French law relating to biomedical research.
You may not qualify if:
- Chemotherapy or radiotherapy before taking tumour samples
- Refusal of the parents or the legal representatives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
Study Sites (27)
Hôpital Nord Amiens
Amiens, 80054, France
Chu Angers
Angers, 49033, France
Chr R.Pellegrin
Bordeaux, 25030, France
CHU MORVAN Brest
Brest, 29609, France
CHR CAEN
Caen, 14033, France
Chu Bocage
Dijon, 21079, France
Chu Grenoble
Grenoble, 38045, France
Chu Lille
Lille, 59020, France
Hopital de La Mere Et de L'Enfant Limoges
Limoges, 87042, France
Centre Leon Berard
Lyon, 69373, France
Hopital D'Enfants de La Timone
Marseille, 13385, France
Hopital Arnaud de Villeneuve
Montpellier, 34059, France
CHR MONCOUSU Nantes
Nantes, 44035, France
CHU Nice Hôpital L'Archet 2
Nice, 06202, France
Institut Curie
Paris, 75005, France
Hôpital Armand TROUSSEAU
Paris, 75571, France
Hôpital Jean Bernard de la Milétrie
Poitiers, 86021, France
Höpital Americain Reims
Reims, 51092, France
CHR Hôpital Sud Rennes
Rennes, 35056, France
Hôpital Charles Nicolle ROUEN
Rouen, 76031, France
Chr Felix Guyon
Saint-Denis, 97405, France
CHU SAINT-ETIENNE Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
Hôpital Hautepierre Strasbourg
Strasbourg, 67098, France
Hôpital des Enfants Toulouse
Toulouse, 31026, France
CHU TOURS Hôpital Clocheville
Tours, 37044, France
Hopital Des Enfants Nancy
Vandœuvre-lès-Nancy, 54500, France
Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gudrun Shleiermacher, MD, PhD
Institut Curie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 12, 2016
Study Start
October 4, 2008
Primary Completion
July 28, 2022
Study Completion
July 1, 2023
Last Updated
December 1, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data requests can be submitted starting 9 months after article publication and will be made accessible for up to 12 months.
- 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).
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.