DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

Recurrent Osteosarcoma Clinical Trial

Official title:

Therapeutically Applicable Research to Generate Effective Treatments (TARGET) for Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190943
• Other study ID #: AOST10B5
• Secondary ID: NCI-2011-02840AO
• Status: Completed
• Start date: August 6, 2010

Study information

• Verified date: March 2022
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. primary completion date: October 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Localized Osteosarcoma
• Metastatic Osteosarcoma
• Osteosarcoma
• Recurrent Osteosarcoma

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Childrens Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression of genes	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.	Baseline
Primary	Incidence of copy number abberations	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 .	Baseline
Primary	Incidence of mutations that occur at a clinically significant frequency		Baseline