Biomarkers in Young Patients With Neuroblastoma

NCT01169376 | Completed

• 4 other identifiers: ANBL10B1COG-ANBL10B1CDR0000681912NCI-2011-02246
• Study Type: observational
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuroblastoma

Keywords

disseminated neuroblastoma; localized resectable neuroblastoma; localized unresectable neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma

Outcome Measures

Primary Outcomes (1)

• Discovery of therapeutically relevant driver mutations

Secondary Outcomes (7)

• 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

Interventions

DNA analysis GENETIC

DNA methylation analysis GENETIC

RNA analysis GENETIC

comparative genomic hybridization GENETIC

mutation analysis GENETIC

polymorphism analysis GENETIC

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered on the COG-ANBL00B1 Neuroblastoma Biology Study

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Neuroblastoma

Interventions

DNA Methylation; Comparative Genomic Hybridization; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Methylation; Alkylation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Genetic Phenomena; Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; DNA Fingerprinting; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• John M. Maris, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 18, 2016

Record last verified: 2016-05