Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

Completed

• Conditions: Localized Osteosarcoma; Metastatic Osteosarcoma; Recurrent Osteosarcoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01807052
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-08
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	laboratory biomarker analysis	Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States