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
  Purpose

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.


Condition Intervention
Localized Osteosarcoma
Metastatic Osteosarcoma
Recurrent Osteosarcoma
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Study of Genetic Risk Factors for Osteosarcoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All osteosarcoma patients seen at COG institutions are eligible

Criteria

Inclusion Criteria:

  • Blood samples collected from clinical trials COG-P9851 and COG-AOST06B1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954473

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Sharon A. Savage, MD    240-276-7241    savagesh@mail.nih.gov   
Principal Investigator: Sharon A. Savage, MD         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Sharon Savage, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00954473     History of Changes
Other Study ID Numbers: AOST08B1, NCI-2011-02192, COG-AOST08B1, CDR0000633101, AOST08B1, AOST08B1, U10CA098543
Study First Received: August 6, 2009
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on October 01, 2014