- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00954473
Study of Blood Samples From Patients With Osteosarcoma
Retrospective Study of Genetic Risk Factors for Osteosarcoma
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Arcadia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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Correlative studies
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hardy-Weinberg equilibrium on all SNPs
Time Frame: Baseline
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Determined on all SNPs by chi-square tests.
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Baseline
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SNPs associated with OS
Time Frame: Baseline
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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.
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Baseline
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Gene-gene interactions
Time Frame: Baseline
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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.
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Baseline
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Survival outcomes
Time Frame: Baseline
|
Kaplan-Meier survival curves will be used to determine outcome relative to genotype.
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Baseline
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Whole-exome variant loci
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sharon Savage, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOST08B1 (Other Identifier: CTEP)
- U10CA098543 (U.S. NIH Grant/Contract)
- NCI-2011-02192 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- COG-AOST08B1 (Other Identifier: Children's Oncology Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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