Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Methylated status as predictor of response to neoadjuvant chemotherapy
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Secondary Outcomes
No secondary outcomes reported