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Completed

NCT Number: NCT00954473

Study of Blood Samples From Patients With 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.

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Key information

Conditions

Localized Osteosarcoma Metastatic Osteosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteosarcoma Recurrent Osteosarcoma Sarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Arcadia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Hardy-Weinberg equilibrium on all SNPs

    Time frame: Baseline

    Determined on all SNPs by chi-square tests.

  2. 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.

  3. 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.

  4. Survival outcomes

    Time frame: Baseline

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

  5. 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Retrospective Study of Genetic Risk Factors for Osteosarcoma

Important dates

Study start
2009
Primary completion
2016
First posted
Aug 7, 2009
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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