Huntsman Biopsy Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Huntsman Cancer Institute
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00615329
First received: February 1, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition
Soft Tissue Sarcoma
Osteosarcoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Huntsman Cancer Institute - The Use of Microarray Analysis in Characterizing Mesenchymal Tissue Tumors: Differentiation of Normal, Benign, and Malignant Conditions

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Classification of sarcomas [ Time Frame: Upon collection/analysis of sarcoma ] [ Designated as safety issue: No ]
    sarcomas will be classified by researchers at Huntsman Institute


Biospecimen Retention:   Samples With DNA

cDNA microarrays facilitate the systematic and comprehensive analysis of transcriptional alterations occurring in diseased tissues.


Estimated Enrollment: 100
Study Start Date: April 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Soft tissue tumor
Any patient with soft tissue tumor will be asked to give a sample for this study

Detailed Description:

as stated in brief summary

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615329

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
Huntsman Cancer Institute
Investigators
Principal Investigator: Timothy A Damron, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Timothy Damron, M.D., Associate Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00615329     History of Changes
Other Study ID Numbers: Huntsman Cancer Institute, IRB 4795
Study First Received: February 1, 2008
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Create tumor specific gene profiles to improve diagnostic accuracy
Perform gene set validation for diagnostic predictive power
Define deviant gene list implicated in pathogenesis

Additional relevant MeSH terms:
Osteosarcoma
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 21, 2014