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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01374672

Enrollment

Registered

2011-06-16

Start date

2011-07-31

Completion date

2011-09-30

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized Osteosarcoma, Metastatic Osteosarcoma, Osteoblastic Osteosarcoma, Recurrent Osteosarcoma

Brief summary

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.

Detailed description

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 20 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Methylated status as predictor of response to neoadjuvant chemotherapy	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026