NCT01466283

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 study is studying biomarkers in patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below 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

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 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 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.6 years

First QC Date

November 2, 2011

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (3)

  • Genome-wide alterations in DNA methylation in ARMS and ERMS

  • Genome-wide DNA copy number alterations in ARMS and ERMS

  • Pathogenic genes and pathways by integrative genomic analysis

Interventions

DNA methylation analysisGENETIC
fluorescence in situ hybridizationGENETIC
gene expression analysisGENETIC
reverse transcriptase-polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Cooperative Human Tissue Network (CHTN)

DISEASE CHARACTERISTICS: * 10 ARMS and 10 ERMS frozen samples will be collected from the COG bank via the Cooperative Human Tissue Network (CHTN) * Human skeletal myoblasts (ZenBio, Research Triangle Park, NC) will serve as controls 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

DNA MethylationIn Situ Hybridization, FluorescenceGene Expression ProfilingReverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationPolymerase Chain ReactionNucleic Acid Amplification Techniques

Study Officials

  • Caroline Y. Hu, MD

    Tomorrows Children's Institute at Hackensack University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 7, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05