DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma
|ClinicalTrials.gov Identifier: NCT01190943|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2010
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment|
|Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma||Other: Laboratory Biomarker Analysis|
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|
|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|
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
- 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.
- 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 .
- Incidence of mutations that occur at a clinically significant frequency [ Time Frame: Baseline ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190943
|United States, Pennsylvania|
|Childrens Oncology Group|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ching Lau||Children's Oncology Group|