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Clinical Trials/NCT01374672
NCT01374672
Completed
Not Applicable

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

Children's Oncology Group1 site in 1 country20 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Localized Osteosarcoma
Sponsor
Children's Oncology Group
Enrollment
20
Locations
1
Primary Endpoint
Methylated status as predictor of response to neoadjuvant chemotherapy
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2011
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

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.

Study Sites (1)

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