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Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification (PHRCNB07)

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuroblastoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Nord Amiens
  • Chu Angers
  • Chr R.Pellegrin
  • CHU MORVAN Brest
  • CHR CAEN
  • Chu Bocage
  • Chu Grenoble
  • Chu Lille
  • Hopital de La Mere Et de L'Enfant Limoges
  • Centre Leon Berard
  • Hopital D'Enfants de La Timone
  • Hopital Arnaud de Villeneuve
  • CHR MONCOUSU Nantes
  • CHU Nice Hôpital L'Archet 2
  • Institut Curie
  • Hôpital Armand TROUSSEAU
  • Hôpital Jean Bernard de la Milétrie
  • Höpital Americain Reims
  • CHR Hôpital Sud Rennes
  • Hôpital Charles Nicolle ROUEN
  • Chr Felix Guyon
  • CHU SAINT-ETIENNE Hôpital Nord
  • Hôpital Hautepierre Strasbourg
  • Hôpital des Enfants Toulouse
  • CHU TOURS Hôpital Clocheville
  • Hopital Des Enfants Nancy
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prospective cohort

Arm Description

Experimental arm, prospective cohort

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2016
Last Updated
October 11, 2023
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02864563
Brief Title
Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
Acronym
PHRCNB07
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 4, 2008 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
July 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective cohort
Arm Type
Experimental
Arm Description
Experimental arm, prospective cohort
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free survival
Description
Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression at metastatic location-Free survival
Description
Time between patient diagnosis and progression/ relapse at metastatic location or death. Correlation with the genomic profile established by CGH-array.
Time Frame
3 years
Title
Overall-Free survival
Description
Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.
Time Frame
3 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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% Inclusion in 4 months following the diagnosis 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: Chemotherapy or radiotherapy before taking tumour samples Refusal of the parents or the legal representatives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gudrun Shleiermacher, MD, PhD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Nord Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Chr R.Pellegrin
City
Bordeaux
ZIP/Postal Code
25030
Country
France
Facility Name
CHU MORVAN Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHR CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Chu Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Chu Grenoble
City
Grenoble
ZIP/Postal Code
38045
Country
France
Facility Name
Chu Lille
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hopital de La Mere Et de L'Enfant Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital D'Enfants de La Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34059
Country
France
Facility Name
CHR MONCOUSU Nantes
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
CHU Nice Hôpital L'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Armand TROUSSEAU
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hôpital Jean Bernard de la Milétrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Höpital Americain Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
CHR Hôpital Sud Rennes
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Hôpital Charles Nicolle ROUEN
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Chr Felix Guyon
City
Saint Denis
ZIP/Postal Code
97405
Country
France
Facility Name
CHU SAINT-ETIENNE Hôpital Nord
City
Saint-priest En Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Hôpital Hautepierre Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital des Enfants Toulouse
City
Toulouse
ZIP/Postal Code
31026
Country
France
Facility Name
CHU TOURS Hôpital Clocheville
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hopital Des Enfants Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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