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DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

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ClinicalTrials.gov Identifier: NCT01190943
Recruitment Status : Active, not recruiting
First Posted : August 30, 2010
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment
Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma Other: Laboratory Biomarker Analysis

Detailed Description:

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.


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
Actual Study Start Date : August 6, 2010
Actual Primary Completion Date : October 1, 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ancillary-Correlative (biomarker sampling and analysis)
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.
Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Tissue


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01190943


Locations
United States, Pennsylvania
Childrens Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ching Lau Children's Oncology Group

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01190943     History of Changes
Other Study ID Numbers: AOST10B5
NCI-2011-02840 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AOST10B5
AOST10B5
CDR0000683276
AOST10B5 ( Other Identifier: Childrens Oncology Group )
AOST10B5 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: November 2017

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