Clinical trial NCT00615329: Huntsman Biopsy Study
Official title: The Huntsman Cancer Institute - The Use of Microarray Analysis in Characterizing Mesenchymal Tissue Tumors: Differentiation of Normal, Benign, and Malignant Conditions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Soft Tissue Sarcoma
Osteosarcoma
Keywords: Create tumor specific gene profiles to improve diagnostic accuracy
Perform gene set validation for diagnostic predictive power
Define deviant gene list implicated in pathogenesis
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: Huntsman Cancer Institute
First posted: 2008-02-14
Enrollment: 142
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who present to Doctor Damron for care relating to a 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 will be approached in the consent process.

Brief 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.

Detailed description: as stated in brief summary

Eligibility criteria: 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

Primary outcomes:
measure: Classification of sarcomas
timeFrame: Upon collection/analysis of sarcoma
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Timothy A Damron, MD
role: PRINCIPAL_INVESTIGATOR
References: