NCT01426945

Brief Summary

RATIONALE: Studying tissue samples from patients with cancer 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 find better ways to treat cancer. PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 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

August 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.5 years

First QC Date

August 31, 2011

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

alveolar childhood rhabdomyosarcomapreviously treated childhood rhabdomyosarcomapreviously untreated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcomaembryonal childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • RMS protein expression profile

Interventions

protein expression analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials

DISEASE CHARACTERISTICS: * Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials * Alveolar rhabdomyosarcoma (ARMS) * Embryonal rhabdomyosarcoma (ERMS) 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

Tumor tissue

MeSH Terms

Conditions

Sarcoma

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

HistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic Techniques

Study Officials

  • Corinne M. Linardic, MD, PhD

    Duke Cancer Institute

    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

August 31, 2011

First Posted

September 1, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05