NCT01609803

Brief Summary

This research trial studies protein expression in tissue samples from younger patients with rhabdomyosarcoma. 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. It may also help doctors find better ways to treat cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3.9 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

3.9 years

First QC Date

May 30, 2012

Last Update Submit

May 16, 2016

Conditions

Alveolar Childhood RhabdomyosarcomaEmbryonal Childhood RhabdomyosarcomaPreviously Treated Childhood RhabdomyosarcomaPreviously Untreated Childhood RhabdomyosarcomaRecurrent Childhood Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (1)

  • Amplification and fusion status as a result of the 12q13-q14 amplification event

    Fisher's exact test will be used. For a contingency table other than 2 x 2, the Freeman-Halton test (an extension of Fisher's exact test) will be applied instead.

    Baseline

Study Arms (1)

Correlative studies

Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Correlative studies

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Tissue samples from younger patients with rhabdomyosarcoma from 2006

You may qualify if:

  • Slides of the 2006 alveolar rhabdomyosarcoma (ARMS) TMA and the 2009 ARMS/anaplastic embryonal rhabdomyosarcoma (ERMS) TMA
  • PAX3-FOXO1-positive tumors
  • PAX7-FOXO1-positive tumors
  • Fusion-negative tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue samples

Study Officials

  • Frederick Barr, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 1, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)