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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


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
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