Biomarkers in Young Patients With Neuroblastoma
Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Neuroblastoma
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is studying biomarkers in young patients with neuroblastoma.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
Primary
- To discover the therapeutically relevant driver mutations in high-risk pediatric neuroblastoma.
Secondary
- To identify a set of highly annotated neuroblastoma specimens (primary tumors and cell lines) for comprehensive genomic analyses, validation studies, resequencing efforts, and future functional assays.
- To define genome-wide DNA copy number and allelic status in at least 300 high-risk and 50 low-risk neuroblastoma primary untreated tumors, and 30 human neuroblastoma-derived cell lines.
- To define the genome-wide methylation profile of neuroblastoma in a minimum of 200 high-risk cases.
- To define the genome-wide microRNA expression profile of neuroblastoma in a minimum of 200 high-risk cases.
- To define genome-wide RNA expression signatures, including splice variations, in the same tumors and cell lines studied above.
- To identify mutations in candidate therapeutic targets using a staged resequencing strategy with ultimate genome-scale next generation resequencing of 3 genomes for 200 high-risk cases: the neuroblastoma genome and transcriptome as well as the paired constitutional genome.
- To characterize the relapsed high-risk neuroblastoma genome and epigenome.
OUTLINE: This is a multicenter study.
Previously collected samples are analyzed to define the genome-wide DNA copy number and allelic status; to define the genome-wide methylation profile of high-risk neuroblastoma cases; to define the genome-wide microRNA expression profile of high-risk neuroblastoma cases; to define the genome-wide RNA expression and relating gene expression to DNA copy number and gene polymorphisms, DNA methylation, and microRNA expression; to resequence three genomes: the neuroblastoma genome, the transcriptome, and the paired constitutional genome; and to characterize the relapsed high-risk neuroblastoma genome and epigenome.
PROJECTED ACCRUAL: A total of 300 tumor samples from patients with high-risk disease, 50 tumor samples from patients with low-risk primary neuroblastoma, and 30 human neuroblastoma-derived cell lines will be accrued for this study.
Type d'étude
Inscription (Anticipé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
DISEASE CHARACTERISTICS:
- Registered on the COG-ANBL00B1 Neuroblastoma Biology Study or its CCG or POG precursor
Sufficient high-quality tumor material available for the proposed studies meeting the following criteria:
- Tissue histopathologic review with > 70% tumor cells in sections adjacent to areas used for nucleic acid preparation
- Matched normal cells (blood or uninvolved bone marrow) available
- ≥ 5 μg DNA available
- ≥ 5 μg RNA available
- ≥ 200 mg tissue available
Tumor samples must meet 1 of the following criteria:
High-risk tumor
- With or without MYCN amplification
- With or without tumor progression or relapse (during ≥ 2.5 years of follow up)
- Patients aged 18 months to 5 years
Low-risk tumor
- Primary neuroblastoma
- Stage I disease (completely resected)
- No event in ≥ 3 years of follow up
- Cell lines representing diverse high-risk genetics including with or without MYCN amplification and clinical course (at diagnosis or after relapse)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
|---|
|
Discovery of therapeutically relevant driver mutations
|
Mesures de résultats secondaires
Mesure des résultats |
|---|
|
Identification of a set of neuroblastoma specimens for analyses
|
|
Genome-wide DNA copy number and allelic status
|
|
Genome-wide methylation profile
|
|
Genome-wide microRNA expression profile
|
|
Genome-wide RNA expression signatures
|
|
Identification of mutations in candidate therapeutic targets
|
|
Characterization of the relapsed high-risk neuroblastoma genome and epigenome
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par type histologique
- Tumeurs
- Tumeurs, glandulaires et épithéliales
- Tumeurs, neuroépithéliales
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroectodermiques primitives
- Tumeurs neuroectodermiques, primitives, périphériques
- Neuroblastome
Autres numéros d'identification d'étude
- ANBL10B1
- COG-ANBL10B1 (Autre identifiant: Children's Oncology Group)
- CDR0000681912 (Autre identifiant: Clinical Trials.gov)
- NCI-2011-02246 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .