Studying Tumor Samples From Young Patients With Neuroblastoma
Sleutelwoorden
Abstract
Omschrijving
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients previously enrolled on clinical trial COG-ANBL00B1 Sampling Method: Non-Probability Sample
PRIMARY OBJECTIVE:
I. To comprehensively identify and characterize the spectrum and frequency of mutations in ALK across all neuroblastoma disease subsets using methodologies that will be resource neutral to the Children's Oncology Group Neuroblastoma Nucleic Acids Bank.
SECONDARY OBJECTIVES:
I. To formulate genetic screening recommendations for newly diagnosed patients with or without a family history of neuroblastoma.
II. To identify the functionally relevant ALK mutations that can be pharmacologically inhibited.
III. To test for the prognostic capability of ALK alterations. IV. To determine the clinical significance of ALK mutations and/or genomic rearrangements by combining ALK mutation, amplification, and translocation data overall and within each neuroblastoma risk group and correlating this information with clinical phenotype (i.e., age, International Neuroblastoma Staging System stage, and International Neuroblastoma Pathology Classification); genetic factors (i.e., ploidy, MYCN status); and patient outcome.
OUTLINE:
Tumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for single nucleotide polymorphisms (SNPs) by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy).
A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel.
Datums
Laatst geverifieerd: | 04/30/2015 |
Eerste ingediend: | 05/21/2009 |
Geschatte inschrijving ingediend: | 05/21/2009 |
Eerst geplaatst: | 05/24/2009 |
Laatste update ingediend: | 05/11/2015 |
Laatste update geplaatst: | 05/12/2015 |
Werkelijke startdatum van het onderzoek: | 11/30/2008 |
Geschatte primaire voltooiingsdatum: | 11/30/2008 |
Geschatte voltooiingsdatum van het onderzoek: | 11/30/2008 |
Conditie of ziekte
Interventie / behandeling
Other: Correlative studies
Fase
Armgroepen
Arm | Interventie / behandeling |
---|---|
Correlative studies Tumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for SNPs by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy).
A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel. | Other: Correlative studies Correlative studies |
Geschiktheidscriteria
Geslachten die in aanmerking komen voor studie | All |
Bemonsteringsmethode | Non-Probability Sample |
Accepteert gezonde vrijwilligers | Ja |
Criteria | Inclusion Criteria: - Tumor DNA samples available from pediatric patients with newly diagnosed neuroblastoma previously enrolled on clinical trial COG-ANBL00B1 |
Resultaat
Primaire uitkomstmaten
1. Event-free survival (EFS) [Up to 1 year]
Secundaire uitkomstmaten
1. Overall survival [Up to 1 year]
2. Disease progression as assessed by International Neuroblastoma Response Criteria [From the time of diagnosis until the time of first occurrence of relapse, progression, secondary malignancy, or death, or until the time of last contact if no event occurred, assessed up to 1 year]