Studying Tumor Samples From Young Patients With Neuroblastoma

Neuroblastoma Clinical Trial

Official title:

Observational - Characterizing the Frequency and Spectrum of ALK Mutations in Neuroblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907920
• Other study ID #: ANBL09B1
• Secondary ID: NCI-2009-00501NB
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: May 12, 2015
• Start date: December 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2015
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival (EFS)	Using the log rank test, univariate comparisons of EFS and overall survival (OS) will be made for patients with ALK mutations versus those without ALK mutations.	Up to 1 year	No
Secondary	Overall survival	Using the log rank test, univariate comparisons of EFS and OS will be made for patients with ALK mutations versus those without ALK mutations.	Up to 1 year	No
Secondary	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	No