Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma

This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

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Key information

Conditions

Localized Osteosarcoma Bone Diseases Bone Neoplasms Metastatic Osteosarcoma Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Osteoblastic Osteosarcoma Osteosarcoma Recurrent Osteosarcoma Sarcoma

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Monrovia, California, 91006-3776, United States

About this study

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma.

OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor).

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with high-grade osteoblastic osteosarcoma
Biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available
All specimens should be from post-menarchal females or age-matched males with appendicular tumors
Patients' clinical data including chemotherapy received, event-free survival, and overall survival available
See Disease Characteristics

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

Methylated status as predictor of response to neoadjuvant chemotherapy

Time frame: Baseline

Performed on a locus-by-locus basis using Poisson regression (for count data) and/or two-group t-tests, with correction (Satterwaithe's) for unequal within-group variances.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jun 16, 2011
Registry last updated: May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed