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NCT01374672 Clinical Trial

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

Recurrent Osteosarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01374672
Other study ID # AOST11B1
Secondary ID NCI-2011-02861
Status Completed
Phase N/A
First received June 15, 2011
Last updated May 8, 2015
Start date July 2011
Est. completion date September 2011

Study information
Verified date May 2015
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 20 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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