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
2 other identifiers
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2011
CompletedFirst Posted
Study publicly available on registry
June 16, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 12, 2015
May 1, 2015
2 months
June 15, 2011
May 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Methylated status as predictor of response to neoadjuvant chemotherapy
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.
Baseline
Study Arms (1)
Correlative studies
DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.
Interventions
Eligibility Criteria
Diagnosed with high-grade osteoblastic osteosarcoma.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Children's Oncology Group
Monrovia, California, 91006-3776, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Rosenblum, MD
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2011
First Posted
June 16, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
May 12, 2015
Record last verified: 2015-05