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NCT Number: NCT01190943

DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

This research study is studying DNA biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes the occur in DNA and identify biomarkers related to cancer. DNA analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

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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

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

About this study

OBJECTIVES:

I. To comprehensively detect genomic, epigenomic, and transcriptomic aberrations in tissue samples from patients with osteosarcoma that may play a role in chemoresistance and metastasis using high-resolution genome-wide technologies.

II. To identify recurrent genetic mutations involved in the pathogenesis of osteosarcoma, especially for the development of chemoresistance and metastatic tumors.

III. To identify and validate these biomarkers for new therapeutic targets for patients with osteosarcoma, especially those with metastatic disease and whose tumors are resistant to standard chemotherapy.

OUTLINE: This is a multicenter study. Archived tumor tissue and peripheral blood DNA specimens are analyzed for DNA copy number profiling, gene expression profiling, DNA methylation profiling, microRNA profiling, and genomic resequencing. Clinical data including demographics; date of diagnosis, surgery, chemotherapy, recurrence, progression, and death; imaging; toxicity; and pathologic data elements associated with the specimens are also collected and analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of osteosarcoma
  • Fresh-frozen samples collected at the time of diagnosis with matchedblood DNA (preferred) from patients enrolled on the following osteosarcoma biology protocols:
  • COG-P9851
  • COG-AOST06B1
  • Available clinical outcome data
  • Not specified
  • Not specified

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Expression of genes

    Time frame: Baseline

    The Significance Analysis of Microarrays (SAM) algorithm will be used for analysis of differential expression. Pathway analysis and data integration will be performed on the differentially expressed genes using Ingenuity Pathway Analysis. Differentially expressed genes and miRNA targets as well as genes in the significant DNA aberrations will be mapped and integrated to identify the enriched pathways and networks.

  2. Incidence of copy number abberations

    Time frame: Baseline

    The array data will be imported to Copy Number Analyzer (CNAG) for GeneChip mapping arrays to identify copy number aberrations in the tumor samples. To identify regions with frequent CNA among different groups of patient samples, we will use the Genomic Identification of Significant Targets in Cancer (GISTIC) tool .

  3. Incidence of mutations that occur at a clinically significant frequency

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma

Important dates

Study start
2010
Primary completion
2010
First posted
Aug 30, 2010
Registry last updated
Mar 28, 2022

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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