DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01190943

Collaborator

National Cancer Institute (NCI) (NIH)

125

Enrollment

Location

Study Details

Study Description

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	Phase
Localized Osteosarcoma Metastatic Osteosarcoma Recurrent Osteosarcoma	Other: Laboratory Biomarker Analysis

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.

Study Design

Study Type:

Observational

Actual Enrollment :

125 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 6, 2010

Actual Primary Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Expression of genes [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 [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 [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Childrens Oncology Group	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Children's Oncology Group
National Cancer Institute (NCI)

Investigators

Principal Investigator: Ching C Lau, Children's Oncology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Children's Oncology Group

ClinicalTrials.gov Identifier:

NCT01190943

Other Study ID Numbers:

AOST10B5
NCI-2011-02840
AOST10B5
CDR0000683276
COG-AOST10B5
AOST10B5
AOST10B5
U10CA098543

First Posted:

Aug 30, 2010

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteosarcoma

Study Results

No Results Posted as of Mar 28, 2022