DNA Biomarkers in Tissue Samples From Patients With Osteosarcoma

NCT01190943 | Completed

• 5 other identifiers: AOST10B5NCI-2011-02840CDR0000683276COG-AOST10B5U10CA098543
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Osteosarcoma; Metastatic Osteosarcoma; Recurrent Osteosarcoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Incidence of mutations that occur at a clinically significant frequency

  Baseline

Study Arms (1)

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Ancillary-Correlative (biomarker sampling and analysis)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PATIENTS WITH OSTEOSARCOMA WITH SPECIMENS COLLECTED AND BANKED ON THE OS BIOLOGY PROTOCOL (P9851) OR THE REPLACEMENT AOST06B1

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Childrens Oncology Group

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

FRESH FROZEN TISSUE, BLOOD DNA

MeSH Terms

Conditions

Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Ching C Lau

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: August 6, 2010
• Primary Completion: October 1, 2010
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (1)