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

Completed

• Conditions: Localized Osteosarcoma; Osteoblastic Osteosarcoma; Recurrent Osteosarcoma; Metastatic Osteosarcoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01374672
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2011-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative studies	laboratory biomarker analysis	DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States