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DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01190943
First received: August 27, 2010
Last updated: October 30, 2010
Last verified: August 2010

August 27, 2010
October 30, 2010
August 2010
October 2010   (final data collection date for primary outcome measure)
Identification and validation of biomarkers with potential clinical utility [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01190943 on ClinicalTrials.gov Archive Site
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DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma
Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma

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.

OBJECTIVES:

  • 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.

Observational
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
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October 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01190943
CDR0000683276, COG-AOST10B5
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Gregory H. Reaman, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Ching C. Lau, MD, PhD Texas Children's Cancer Center
National Cancer Institute (NCI)
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP