NCT01047878

Brief Summary

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)).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

10.8 years

First QC Date

January 11, 2010

Last Update Submit

July 24, 2020

Conditions

Bone Cancer

Outcome Measures

Primary Outcomes (2)

  • % necrosis post chemotherapy

    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

    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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor samples and blood

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Arun A Rangaswami

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 13, 2010

Study Start

August 1, 2007

Primary Completion

June 1, 2018

Study Completion

December 1, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

US(1)