NeuroblastomaPHRCNB07NCT02864563
Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
A study testing Blood sampling in people with Neuroblastoma, run by Institut Curie at 27 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 27 sitesFrance
- Study dates
- 4 Oct 2008to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Chemotherapy or radiotherapy before taking tumour samples
- Refusal of the parents or the legal representatives
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
France27 sites
Hôpital Nord Amiens
Amiens, 80054
Chu Angers
Angers, 49033
Chr R.Pellegrin
Bordeaux, 25030
CHU MORVAN Brest
Brest, 29609
CHR CAEN
Caen, 14033
Chu Bocage
Dijon, 21079
Chu Grenoble
Grenoble, 38045
Chu Lille
Lille, 59020
Hopital de La Mere Et de L'Enfant Limoges
Limoges, 87042
Centre Leon Berard
Lyon, 69373
Hopital D'Enfants de La Timone
Marseille, 13385
Hopital Arnaud de Villeneuve
Montpellier, 34059
CHR MONCOUSU Nantes
Nantes, 44035
CHU Nice Hôpital L'Archet 2
Nice, 06202
Institut Curie
Paris, 75005
Hôpital Armand TROUSSEAU
Paris, 75571
Hôpital Jean Bernard de la Milétrie
Poitiers, 86021
Höpital Americain Reims
Reims, 51092
CHR Hôpital Sud Rennes
Rennes, 35056
Hôpital Charles Nicolle ROUEN
Rouen, 76031
Chr Felix Guyon
Saint-Denis, 97405
CHU SAINT-ETIENNE Hôpital Nord
Saint-Priest-en-Jarez, 42270
Hôpital Hautepierre Strasbourg
Strasbourg, 67098
Hôpital des Enfants Toulouse
Toulouse, 31026
CHU TOURS Hôpital Clocheville
Tours, 37044
Hopital Des Enfants Nancy
Vandœuvre-lès-Nancy, 54500
Gustave Roussy
Villejuif, 94805
About this study
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.
Read the 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.
- Conditions
- Neuroblastoma
- Being tested
- Blood sampling
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Experimental | Experimental arm, prospective cohort Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free survival
Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.
Measured: 3 years
Secondary outcomes (2)
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.
Measured: 3 years
Overall-Free survival
Time between patient diagnosis and death.Correlation with the genomic profile established by CGH-array.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start4 Oct 2008
- Primary completion28 Jul 2022
- Study completionJul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gudrun Shleiermacher, MD, PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864563
- Sponsor's protocol ID
- IC 2007-09
- Acronym
- PHRCNB07
- Status last verified
- Nov 2023
- First submitted
- 9 Aug 2016
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-genome Analysis of Neuroblastoma by Comparative Genomic Hybridization and Correlation With Pathology for the Diagnostic and the Prognostic Classification
- ClinicalTrials.gov ID
- NCT02864563
- Acronym / sponsor ID
- PHRCNB07 / IC 2007-09
- Conditions
- Neuroblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 4 Oct 2008 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- Jul 2023 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | Experimental | Procedure: Blood samplingExperimental arm, prospective cohort |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Chemotherapy or radiotherapy before taking tumour samples
- Refusal of the parents or the legal representatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling* 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. | Procedure or surgery | Prospective cohort |
Primary outcome
Progression-Free survival
Time frame: 3 years
Time between patient diagnosis and tumoral progression or relapse or death. Correlation with the genomic profile established by CGH-array.
2 secondary outcomes
Progression at metastatic location-Free survival
Time frame: 3 years
Overall-Free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Neuroblastoma
RecruitingPhase 1/2
Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse
Recurrent Ganglioneuroblastoma, Recurrent Neuroblastoma
Active, not recruitingObservational study
Genomic Structural Variation in Cancer Susceptibility
Breast Cancer, Colon Cancer
RecruitingPhase 2
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
Metastatic Chondrosarcoma, Locally Advanced Chondrosarcoma
RecruitingObservational study
Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
Endocrine Tumors, Thyroid Neoplasms
RecruitingPhase 1
PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Neuroblastoma, Diffuse Intrinsic Pontine Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gudrun Shleiermacher, MD, PhD principal investigator
Institut Curie
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Neuroblastoma, run by Institut Curie at 27 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.