Observational - Tissue Factor Expression in Bone Sarcomas
N/A
39 Years
Both
Localized Osteosarcoma, Metastatic Osteosarcoma, Recurrent Osteosarcoma
Trial Information
Observational - Tissue Factor Expression in Bone Sarcomas
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Retrospective
Outcome Measure:
Prevalence of high TF expression
Outcome Description:
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.
Outcome Time Frame:
1 month
Safety Issue:
No
Principal Investigator
Mark Ranalli
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
AOST10B2
NCT ID:
NCT01807052
Start Date:
November 2009
Completion Date:
Related Keywords:
- Localized Osteosarcoma
- Metastatic Osteosarcoma
- Recurrent Osteosarcoma
- Osteosarcoma
- Sarcoma
Name | Location |
|---|---|
| Children's Oncology Group | Arcadia, California 91006-3776 |
