NCT01365962

Brief Summary

RATIONALE: Studying samples of 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. PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 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

June 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.9 years

First QC Date

June 1, 2011

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Degree of surface IGF-IR expression in RMS tumor tissue

  • Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue

Interventions

gene expression analysisGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
mass spectrometryOTHER

Eligibility Criteria

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

Diagnosis of rhabdomyosarcoma.

DISEASE CHARACTERISTICS: * Diagnosis of rhabdomyosarcoma * Alveolar or embryonal rhabdomyosarcoma * Available samples from the Cooperative Human Tissue Network (CHTN) bank 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

MeSH Terms

Conditions

Sarcoma

Interventions

Gene Expression ProfilingImmunohistochemistryMass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesImmunologic TechniquesChemistry Techniques, Analytical

Study Officials

  • Suman Malempati, MD

    Doernbecher Children's Hospital at Oregon Health and Science University

    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

June 1, 2011

First Posted

June 3, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05