NCT01433237

Brief Summary

RATIONALE: Studying samples of blood 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 samples from patients with rhabdomyosarcoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 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

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
4.6 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 19, 2016

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

September 9, 2011

Last Update Submit

May 17, 2016

Conditions

Sarcoma

Keywords

embryonal childhood rhabdomyosarcomaadult rhabdomyosarcomaalveolar childhood rhabdomyosarcomaadult soft tissue sarcomachildhood rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • Serum miR-206 as a biomarker for RMS

Interventions

RNA analysisGENETIC
gene expression analysisGENETIC
laboratory biomarker analysisOTHER

Eligibility Criteria

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

Rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS.

DISEASE CHARACTERISTICS: * Serum specimens of rhabdomyosarcoma (RMS), embryonal RMS, and non-RMS available from the Soft Tissue Sarcoma committee of Children's Oncology Group 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

SarcomaRhabdomyosarcoma

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMyosarcomaNeoplasms, Muscle Tissue

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Hajime Hosoi, MD

    Kyoto Prefectural University of Medicine

    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

September 9, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 19, 2016

Record last verified: 2016-05