Observational - Tissue Factor Expression in Bone Sarcomas
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Localized Osteosarcoma
- Sponsor
- Children's Oncology Group
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Prevalence of high TF expression
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer
Detailed Description
STUDY SUBTYPE: Ancillary/Correlative OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples without DNA BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN) STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials SAMPLING METHOD: Non-probability sample PRIMARY OBJECTIVES: I. To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma. II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression. III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases. OUTLINE: Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Tissue samples from patients with osteosarcomas obtained from the CHTN:
- •P9754 clinical trial for patients with non-metastatic osteosarcoma
- •AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prevalence of high TF expression
Time Frame: 1 month
Estimated in the analytic population as the number of samples in the population in which such expression is noted divided by 33. An assessment of the precision of such estimates will be provided by an exact binomial confidence interval. Comparison of normalized TF expression in non-metastatic versus metastatic patients will be done using the two-sample t-test.