NCT00898053

Brief Summary

This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

7.7 years

First QC Date

May 9, 2009

Last Update Submit

May 13, 2016

Conditions

Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

    Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, assessed up to 3 years

Secondary Outcomes (2)

  • Incidence of p53 mutations using the model of Sather and Sposto

    Baseline

  • Incidence of p16 loss or deletion using the model of Sather and Sposto

    Baseline

Study Arms (1)

Correlative studies

Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Correlative studies

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of Ewing sarcoma

You may qualify if:

  • Diagnosis of Ewing sarcoma
  • Banked specimens from patients enrolled on AEWS0031

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor samples

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive, Peripheral

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Stephen Lessnick, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

September 1, 2008

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)