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Genomic Analysis of Pediatric Bone Tumors

This study is currently recruiting participants.
Verified April 2016 by Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047878
First Posted: January 13, 2010
Last Update Posted: April 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stanford University
  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:


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 ]
  • 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. ]

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 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047878


Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Alejandro Sweet-Cordero    650-725-5901    ascor@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Sub-Investigator: Neyssa Marina, MD         
Principal Investigator: Alejandro Sweet-Cordero, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alejandro Sweet-Cordero, MD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01047878     History of Changes
Other Study ID Numbers: PEDSSARC0001
97630 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-12082009-4522 ( Other Identifier: Stanford University )
First Submitted: January 11, 2010
First Posted: January 13, 2010
Last Update Posted: April 26, 2016
Last Verified: April 2016

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