Studying Tumor Samples From Young Patients With Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00907920
First received: May 22, 2009
Last updated: April 21, 2010
Last verified: June 2009

May 22, 2009
April 21, 2010
December 2008
November 2009   (final data collection date for primary outcome measure)
Event-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907920 on ClinicalTrials.gov Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Disease progression as assessed by International Neuroblastoma Response Criteria [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Studying Tumor Samples From Young Patients With Neuroblastoma
Characterizing the Frequency and Spectrum of ALK Mutations in Neuroblastoma

RATIONALE: 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.

PURPOSE: This research study is looking at tumor samples from young patients with neuroblastoma.

OBJECTIVES:

Primary

  • 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

  • To formulate genetic screening recommendations for newly diagnosed patients with or without a family history of neuroblastoma.
  • To identify the functionally relevant ALK mutations that can be pharmacologically inhibited.
  • To test for the prognostic capability of ALK alterations.
  • 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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Neuroblastoma
  • Genetic: DNA analysis
  • Genetic: mutation analysis
  • Genetic: nucleic acid sequencing
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
Not Provided
November 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Tumor DNA samples available from pediatric patients with newly diagnosed neuroblastoma previously enrolled on clinical trial COG-ANBL00B1

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
up to 30 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00907920
CDR0000626352, COG-ANBL09B1
Not Provided
Not Provided
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Yael P. Mosse, MD Children's Hospital of Philadelphia
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP