Study of Blood Samples From Patients With Osteosarcoma

Recurrent Osteosarcoma Clinical Trial

Official title:

Retrospective Study of Genetic Risk Factors for Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954473
• Other study ID #: AOST08B1
• Secondary ID: NCI-2011-02192CO
• Status: Completed
• Phase: N/A
• First received: August 6, 2009
• Last updated: May 17, 2016
• Start date: January 2009

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Localized Osteosarcoma
• Metastatic Osteosarcoma
• Osteosarcoma
• Recurrent Osteosarcoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Arcadia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hardy-Weinberg equilibrium on all SNPs	Determined on all SNPs by chi-square tests.	Baseline	No
Primary	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	No
Primary	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	No
Primary	Survival outcomes	Kaplan-Meier survival curves will be used to determine outcome relative to genotype.	Baseline	No
Primary	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	No