NCT01585376

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and find biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies genes in samples from younger patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2012

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

April 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
4 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 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4.1 years

First QC Date

April 24, 2012

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

alveolar childhood rhabdomyosarcomaembryonal childhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • Frequency of particular genetic lesions

  • Identification of mutations that occur in at least 5% of rhabdomyosarcomas as a whole

Interventions

mutation analysisGENETIC
nucleic acid sequencingGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Patients diagnosed with rhabdomyosarcoma

DISEASE CHARACTERISTICS: * Matched genomic deoxyribonucleic acid (DNA) from tumor and germline samples from patients diagnosed with rhabdomyosarcoma (alveolar or embryonal) 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

Base Sequence

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Molecular StructureBiochemical PhenomenaChemical PhenomenaGenetic StructuresGenetic Phenomena

Study Officials

  • Alberto S. Pappo, MD

    St. Jude Children's Research Hospital

    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

April 24, 2012

First Posted

April 25, 2012

Study Start

April 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05