NCT01480518

Brief Summary

RATIONALE: Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research study is studying biomarkers in tissue samples from patients with Ewing sarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

November 22, 2011

Last Update Submit

May 8, 2015

Conditions

Sarcoma

Keywords

localized Ewing sarcoma/peripheral primitive neuroectodermal tumor

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

Interventions

DNA analysisGENETIC
comparative genomic hybridizationGENETIC
gene expression analysisGENETIC
mutation analysisGENETIC
polymerase chain reactionGENETIC
polymorphic microsatellite marker analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Ewing sarcoma.

DISEASE CHARACTERISTICS: * Specimens from patients with Ewing sarcoma used for protocol COG-AEWS08B1 * Obtained from patient samples taken from patients enrolled on COG-AEWS0031 * Whole genome-amplified DNA will be used PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

SarcomaNeuroectodermal Tumors, Primitive, Peripheral

Interventions

Comparative Genomic HybridizationGene Expression ProfilingPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cytogenetic AnalysisGenetic TechniquesInvestigative TechniquesMolecular Diagnostic TechniquesNucleic Acid HybridizationNucleic Acid Amplification Techniques

Study Officials

  • Stephen Lessnick, MD, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 29, 2011

Study Start

December 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 12, 2015

Record last verified: 2015-05