Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

Recurrent Osteosarcoma Clinical Trial

Official title:

Observational - Tissue Factor Expression in Bone Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807052
• Other study ID #: AOST10B2
• Secondary ID: NCI-2013-00112CO
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: May 17, 2016
• Start date: November 2009
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 39 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Localized Osteosarcoma
• Metastatic Osteosarcoma
• Osteosarcoma
• Recurrent Osteosarcoma

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	Prevalence of high TF expression	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.	1 month	No