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Clinical Trials/NCT00954473
NCT00954473
Completed
Not Applicable

Retrospective Study of Genetic Risk Factors for Osteosarcoma

Children's Oncology Group1 site in 1 country1,000 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Localized Osteosarcoma
Sponsor
Children's Oncology Group
Enrollment
1000
Locations
1
Primary Endpoint
SNPs associated with OS
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This research trial studies blood samples from patients with osteosarcoma. Studying the genes found in samples of blood from patients with osteosarcoma may help doctors identify biomarkers related to the disease.

Detailed Description

PRIMARY OBJECTIVE: I. Conduct a large-scale candidate gene association study in osteosarcoma (OS) using cases from the national Children's Oncology Group (COG) OS biology study (P9851 and successor study AOST06B1). SECONDARY OBJECTIVES: I. Conduct a genome-wide association study (GWAS) of OS. II. Fine-map genomic regions associated with OS to identify putative functional loci. III. Conduct whole-exome sequencing of germline OS deoxyribonucleic acid (DNA) samples. IV. Investigate the functional implications of promising genetic variants associated with OS. OUTLINE: Blood samples undergo polymorphism analysis of common single-nucleotide polymorphisms and haplotypes to examine genetic variation, gene-gene interactions, and the population structure.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

SNPs associated with OS

Time Frame: Baseline

Logistic regression will be used to estimate odds ratios and 95% confidence intervals for the association between each SNP and OS under co-dominant, dominant and recessive genetic models. Stratified analyses will be conducted to examine sex, tumor subtype and outcome differences.

Gene-gene interactions

Time Frame: Baseline

Assessed using a multiplicative model. Haplotypes will be constructed using both Bayesian and expectation-maximization algorithms. Differences between cases and controls will be evaluated with HaploStats which uses haplotype posterior probabilities as weights to update the regression coefficients in an iterative manner.

Hardy-Weinberg equilibrium on all SNPs

Time Frame: Baseline

Determined on all SNPs by chi-square tests.

Whole-exome variant loci

Time Frame: Baseline

Annotation and filtering of each whole-exome variant locus will be performed using a custom software pipeline. Variants in \>= 2 OS cases will be validated, and then subsequently replicated in additional OS cases (samples previously received for the GWAS from international collaborators). Variants will also be evaluated for presence in known biologically plausible pathways and genes.

Survival outcomes

Time Frame: Baseline

Kaplan-Meier survival curves will be used to determine outcome relative to genotype.

Study Sites (1)

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