NCT01419509

Brief Summary

RATIONALE: DNA analysis of tumor, blood, and bone marrow may help doctors predict if the disease has been disseminated. PURPOSE: This research trial studies DNA tests in detecting disseminated disease in tumor, blood, and bone marrow samples from patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than 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

Study Start

First participant enrolled

August 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
4.7 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

4.8 years

First QC Date

August 17, 2011

Last Update Submit

May 13, 2016

Conditions

Sarcoma

Keywords

alveolar childhood rhabdomyosarcomaembryonal childhood rhabdomyosarcomaembryonal-botryoid childhood rhabdomyosarcomamixed childhood rhabdomyosarcomapleomorphic childhood rhabdomyosarcomapreviously untreated childhood rhabdomyosarcomanonmetastatic childhood soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

  • Panel of hypermethylation assays for minimal disseminated RMS

  • Detection of RMS cells in bone marrow

Interventions

DNA methylation analysisGENETIC
microarray analysisGENETIC
polymerase chain reactionGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Diagnosed with rhabdomyosarcoma

DISEASE CHARACTERISTICS: * Diagnosed with rhabdomyosarcoma (RMS) * Tumor, bone marrow, and peripheral blood samples from the Children's Oncology Group D9803 trial of intermediate-risk RMS 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, Blood, and Bone Marrow Samples

MeSH Terms

Conditions

Sarcoma

Interventions

DNA MethylationMicroarray AnalysisPolymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaMicrochip Analytical ProceduresInvestigative TechniquesNucleic Acid Amplification TechniquesGenetic Techniques

Study Officials

  • Stephen R. Master, MD

    University of Pennsylvania

    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 17, 2011

First Posted

August 18, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05