NCT00615329

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. 1.creating tumor specific gene profiles to improve diagnostic accuracy
  2. 2.performing gene set validation for diagnostic predictive power
  3. 3.defining a discriminate gene list implicated in pathogenesis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

10.8 years

First QC Date

February 1, 2008

Last Update Submit

November 24, 2014

Conditions

Keywords

Create tumor specific gene profiles to improve diagnostic accuracyPerform gene set validation for diagnostic predictive powerDefine deviant gene list implicated in pathogenesis

Outcome Measures

Primary Outcomes (1)

  • Classification of sarcomas

    sarcomas will be classified by researchers at Huntsman Institute

    Upon collection/analysis of sarcoma

Study Arms (1)

Soft tissue tumor

Any patient with soft tissue tumor will be asked to give a sample for this study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Non cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

SarcomaOsteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective Tissue

Study Officials

  • Timothy A Damron, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

April 1, 2003

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations