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Genomic Analysis of Pediatric Bone Tumors

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01047878
First received: January 11, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).


Condition
Bone Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Genomic Analysis of Pediatric Bone Tumors (Other Title: Pediatric Bone Tumor Biology Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • % necrosis post chemotherapy [ Time Frame: his is measured at the time of sample collection since we are looking for % necrosis in the sample we are collecting ] [ Designated as safety issue: No ]
  • overall survival and event free survival [ Time Frame: This is measured at the time the patient dies, or at the time when patient relapses from their disease. There is no set time since this outcome is individually assessed. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

tumor samples and blood


Estimated Enrollment: 150
Study Start Date: August 2007
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients with bone x-rays suggestive of a malignant bone tumor

Criteria

Inclusion Criteria:All patients with bone x-rays suggestive of a malignant bone tumor

Exclusion Criteria:Patients with a known diagnosis of cancer.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047878

Contacts
Contact: Lolita Penland (650) 736-2753 lpenland@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Lolita Penland     650-736-2753     lpenland@stanford.edu    
Contact: Cancer Clinical Trials Office     (650) 498-7061        
Sub-Investigator: Dr. Neyssa Maria Marina            
Principal Investigator: Dr. Alejandro Sweet-Cordero            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Alejandro Sweet-Cordero Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01047878     History of Changes
Other Study ID Numbers: PEDSSARC0001, 97630, SU-12082009-4522
Study First Received: January 11, 2010
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013