Ignite Creation Date:
2024-05-05 @ 9:32 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00907920
Status:
COMPLETED
Last Update Posted:
2015-05-13
First Post:
2009-05-22
Brief Title:
Studying Tumor Samples From Young Patients With Neuroblastoma
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Observational - Characterizing the Frequency and Spectrum of ALK Mutations in Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is looking at tumor samples from young patients with neuroblastoma Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer
Detailed Description:
Study Subtype AncillaryCorrelative 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 Childrens 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 andor genomic rearrangements by combining ALK mutation amplification and translocation data overall and within each neuroblastoma risk group and correlating this information with clinical phenotype ie age International Neuroblastoma Staging System stage and International Neuroblastoma Pathology Classification genetic factors ie 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 ie 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
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 Childrens 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 andor genomic rearrangements by combining ALK mutation amplification and translocation data overall and within each neuroblastoma risk group and correlating this information with clinical phenotype ie age International Neuroblastoma Staging System stage and International Neuroblastoma Pathology Classification genetic factors ie 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NB 2008-08 | OTHER | Childrens Oncology Group | None |
| NCI-2009-00501 | REGISTRY | None | None |