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
  Purpose

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 Intervention
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

Study Type: Observational
Official Title: Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification and validation of biomarkers with potential clinical utility [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01190943

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Ching C. Lau, MD, PhD Texas Children's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01190943     History of Changes
Other Study ID Numbers: CDR0000683276, COG-AOST10B5
Study First Received: August 27, 2010
Last Updated: October 30, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized osteosarcoma
metastatic osteosarcoma
recurrent osteosarcoma

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

ClinicalTrials.gov processed this record on August 19, 2014