- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01169376
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
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Discovery of therapeutically relevant driver mutations
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Misure di risultato secondarie
Misura del risultato |
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Identification of a set of neuroblastoma specimens for analyses
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Genome-wide DNA copy number and allelic status
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Genome-wide methylation profile
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Genome-wide microRNA expression profile
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Genome-wide RNA expression signatures
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Identification of mutations in candidate therapeutic targets
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Characterization of the relapsed high-risk neuroblastoma genome and epigenome
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Collaboratori e investigatori
Sponsor
Collaboratori
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ANBL10B1
- COG-ANBL10B1 (Altro identificatore: Children's Oncology Group)
- CDR0000681912 (Altro identificatore: Clinical Trials.gov)
- NCI-2011-02246 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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