Huntsman Biopsy Study

Soft Tissue Sarcoma Clinical Trial

Official title:

The Huntsman Cancer Institute - The Use of Microarray Analysis in Characterizing Mesenchymal Tissue Tumors: Differentiation of Normal, Benign, and Malignant Conditions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00615329
• Other study ID #: Huntsman Cancer Institute
• Secondary ID: IRB 4795
• Status: Terminated
• Phase: N/A
• First received: February 1, 2008
• Last updated: November 24, 2014
• Start date: April 2003
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Bone and soft tissue sarcomas are currently classified based upon light microscopy supplemented by immunohistochemistry, but within many if not all of these tumor histologic types, considerable heterogeneity exists not only in microscopic appearance but also in biologic behavior and prognosis. Progress in the directed treatment of these tumors, particularly the sarcomas, awaits characterization of the gene profiles for these tumors. Orthopedic oncology researchers at Huntsman Cancer Institute at the University of Utah are establishing a tumor bank for this purpose. The long term objectives of this work include:

1. creating tumor specific gene profiles to improve diagnostic accuracy

2. performing gene set validation for diagnostic predictive power

3. defining a discriminate gene list implicated in pathogenesis

The tissue procured under this protocol at SUNY Upstate Medical University will be limited to excess soft tissue and bone tumor tissue from patients otherwise undergoing clinically indicated procedures for diagnosis or treatment under the care of the local principal investigator (PI) and will be forwarded to the central investigator, R. Lor Randall, MD at Huntsman Cancer Institute for use in the characterization of the gene profiles of these tumors.

Description:

as stated in brief summary

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 142
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Bone or soft tissue tumor that has been established to be or is suspected to possibly be a sarcoma AND who will require a diagnostic or therapeutic surgical procedure which will result in procurement of tissue for histologic review

Exclusion Criteria:

• Non cancer patients

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Huntsman Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Classification of sarcomas	sarcomas will be classified by researchers at Huntsman Institute	Upon collection/analysis of sarcoma	No