DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01190943
Recruitment Status : Active, not recruiting
First Posted : August 30, 2010
Last Update Posted : October 9, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: 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.

PURPOSE: This research study is studying DNA biomarkers in tissue samples from patients with osteosarcoma.

Condition or disease Intervention/treatment
Sarcoma Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: comparative genomic hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: mutation analysis Other: laboratory biomarker analysis

Detailed Description:


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

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma
Study Start Date : August 2010
Estimated Primary Completion Date : January 2100

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Identification and validation of biomarkers with potential clinical utility

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Osteosarcoma


  • Diagnosis of osteosarcoma
  • Fresh-frozen samples collected at the time of diagnosis with matched blood DNA (preferred) from patients enrolled on the following osteosarcoma biology protocols:

    • COG-P9851
    • COG-AOST06B1
  • Available clinical outcome data


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01190943

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Ching C. Lau, MD, PhD Texas Children's Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT01190943     History of Changes
Other Study ID Numbers: AOST10B5
COG-AOST10B5 ( Other Identifier: Children's Oncology Group )
NCI-2011-02840 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AOST10B5 ( Other Identifier: Children's Oncology Group )
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Children's Oncology Group:
localized osteosarcoma
metastatic osteosarcoma
recurrent osteosarcoma

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