- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047878
Genomic Analysis of Pediatric Bone Tumors
July 24, 2020 updated by: Stanford University
Genomic Analysis of Pediatric Bone Tumors (Other Title: Pediatric Bone Tumor Biology Study)
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)).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
163
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with bone x-rays suggestive of a malignant bone tumor
Description
Inclusion Criteria:All patients with bone x-rays suggestive of a malignant bone tumor Exclusion Criteria:Patients with a known diagnosis of cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
% 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
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arun A Rangaswami, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
January 11, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEDSSARC0001
- 97630 (Other Identifier: Stanford University Alternate IRB Approval Number)
- SU-12082009-4522 (Other Identifier: Stanford University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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