Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01062438
First received: February 3, 2010
Last updated: May 5, 2015
Last verified: May 2015

February 3, 2010
May 5, 2015
January 2010
September 2011   (final data collection date for primary outcome measure)
  • Genomic expression profile in osteosarcoma tumor samples using transcriptome sequencing [ Designated as safety issue: No ]
  • Identification of activating and loss of function mutations and gene rearrangement using transcriptome sequencing [ Designated as safety issue: No ]
  • Mutations associated with outcome [ Designated as safety issue: No ]
  • Mutations also found in germ line DNA that predispose the patient to osteosarcoma [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01062438 on ClinicalTrials.gov Archive Site
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Studying DNA in Tumor Tissue Samples From Patients With Localized or Metastatic Osteosarcoma
Genomic Study of Metastatic Osteosarcoma Using Next-Generation Sequencing Technology

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at DNA in tumor tissue samples from patients with localized or metastatic osteosarcoma.

OBJECTIVES:

  • Determine the genomic expression profile in tumor tissue samples from patients with localized or metastatic osteosarcoma using transcriptome sequencing.
  • Identify activating and loss of function mutations and gene rearrangement in these tumor tissue samples using transcriptome sequencing.
  • Identify candidate genes that are important in osteosarcoma and tumorigenesis using genome partition strategies for genomic DNA sequencing.
  • Identify which mutations are associated with outcome.
  • Establish which mutations are also found in germ line DNA that predispose the patient to osteosarcoma.

OUTLINE: DNA and RNA from banked tumor tissue samples and DNA from paired blood samples are analyzed in sequencing studies using next-generation sequencing technology. The sequencing data from these tumor samples are matched to the Human RefSeq (for transcriptome sequencing) and normal human genome in the public databases and to the patient's germ line sequence to identify constitutional and somatic mutations.

Clinical information that is associated with each sample (i.e., age, tumor site, size, primary metastases, response to chemotherapy, surgical remission, follow-up time, and treatment protocol) is also collected, if available.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Retention:   Samples With DNA
Description:

Tumor Tissue

Non-Probability Sample

Diagnosis of localized or metastatic osteosarcoma

Sarcoma
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: gene expression analysis
  • Genetic: gene rearrangement 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.
 
Completed
99
September 2011
September 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of localized or metastatic osteosarcoma
  • Banked snap-frozen tumor tissue samples and paired blood DNA samples available

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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NCT01062438
AOST10B3, COG-AOST10B3, CDR0000665327, NCI-2011-02210
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Javed Khan, MD NCI - Oncogenomics Section
Children's Oncology Group
May 2015

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