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

    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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.

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

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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