Study of Blood Samples From Patients With Osteosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00954473
First received: August 6, 2009
Last updated: August 5, 2014
Last verified: August 2014

August 6, 2009
August 5, 2014
January 2009
January 2100   (final data collection date for primary outcome measure)
  • Hardy-Weinberg equilibrium on all SNPs [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determined on all SNPs by chi-square tests.
  • SNPs associated with OS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Survival outcomes [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Kaplan-Meier survival curves will be used to determine outcome relative to genotype.
  • Whole-exome variant loci [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
Gene associations [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00954473 on ClinicalTrials.gov Archive Site
Not Provided
  • Genome-wide associations [ Designated as safety issue: No ]
  • Genomic regions associated with osteosarcoma [ Designated as safety issue: No ]
  • Functional implications of promising genetic variants associated with osteosarcoma [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Blood Samples From Patients With Osteosarcoma
Retrospective Study of Genetic Risk Factors for Osteosarcoma

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

blood

Probability Sample

All osteosarcoma patients seen at COG institutions are eligible

  • Localized Osteosarcoma
  • Metastatic Osteosarcoma
  • Recurrent Osteosarcoma
Other: laboratory biomarker analysis
Correlative studies
Ancillary-correlative (osteosarcoma genetic risk)
Blood samples undergo polymorphism analysis of common single-nucleotide polymorphisms and haplotypes to examine genetic variation, gene-gene interactions, and the population structure.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
January 2100   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1
Both
Not Provided
No
United States
 
NCT00954473
AOST08B1, NCI-2011-02192, COG-AOST08B1, CDR0000633101, AOST08B1, AOST08B1, U10CA098543
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Sharon Savage, MD Children's Oncology Group
Children's Oncology Group
August 2014

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