Study of Blood Samples From Patients With Osteosarcoma
Retrospective Study of Genetic Risk Factors for Osteosarcoma
4 other identifiers
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedMay 19, 2016
May 1, 2016
7.3 years
August 6, 2009
May 17, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
Hardy-Weinberg equilibrium on all SNPs
Determined on all SNPs by chi-square tests.
Baseline
SNPs associated with OS
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.
Baseline
Gene-gene interactions
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.
Baseline
Survival outcomes
Kaplan-Meier survival curves will be used to determine outcome relative to genotype.
Baseline
Whole-exome variant loci
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.
Baseline
Study Arms (1)
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.
Interventions
Correlative studies
Eligibility Criteria
All osteosarcoma patients seen at COG institutions are eligible
You may qualify if:
- Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Arcadia, California, 91006-3776, United States
Biospecimen
blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sharon Savage, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2016
Last Updated
May 19, 2016
Record last verified: 2016-05