Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609803
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : May 18, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
Alveolar Childhood Rhabdomyosarcoma Embryonal Childhood Rhabdomyosarcoma Previously Treated Childhood Rhabdomyosarcoma Previously Untreated Childhood Rhabdomyosarcoma Recurrent Childhood Rhabdomyosarcoma Other: laboratory biomarker analysis

Detailed Description:


I. To investigate (in two stages) which proteins are overexpressed in association with 12q13-q14 amplification by applying fluorescence in situ hybridization (FISH) and immunohistochemical (IHC) assays to a panel of alveolar rhabdomyosarcomas (ARMS) cases organized into tissue microarrays.


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

Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma
Study Start Date : June 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
Correlative studies

Primary Outcome Measures :
  1. Amplification and fusion status as a result of the 12q13-q14 amplification event [ Time Frame: Baseline ]
    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.

Biospecimen Retention:   Samples With DNA
tissue samples

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tissue samples from younger patients with rhabdomyosarcoma from 2006

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01609803

United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Frederick Barr, MD Children's Oncology Group

Responsible Party: Children's Oncology Group Identifier: NCT01609803     History of Changes
Other Study ID Numbers: ARST12B7
NCI-2012-01972 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST12B7 ( Other Identifier: Children's Oncology Group )
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Rhabdomyosarcoma, Embryonal
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type