Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

Observational - Tissue Factor Expression in Bone Sarcomas

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01807052

Enrollment

Registered

2013-03-08

Start date

2009-11-30

Completion date

2016-05-31

Last updated

2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized Osteosarcoma, Metastatic Osteosarcoma, Recurrent Osteosarcoma

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 39 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of high TF expression	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026