Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Children's Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: May 30, 2012
Last updated: May 12, 2015
Last verified: May 2015

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 Intervention
Alveolar Childhood Rhabdomyosarcoma
Embryonal Childhood Rhabdomyosarcoma
Previously Treated Childhood Rhabdomyosarcoma
Previously Untreated Childhood Rhabdomyosarcoma
Recurrent Childhood Rhabdomyosarcoma
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Amplification and fusion status as a result of the 12q13-q14 amplification event [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 99
Study Start Date: June 2012
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.


Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01609803

United States, California
Children's Oncology Group Recruiting
Monrovia, California, United States, 91006-3776
Contact: Frederic G. Barr, MD    301-594-3780   
Principal Investigator: Frederic G. Barr, MD         
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Frederick Barr, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group Identifier: NCT01609803     History of Changes
Other Study ID Numbers: ARST12B7, NCI-2012-01972, COG-ARST12B7
Study First Received: May 30, 2012
Last Updated: May 12, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhabdomyosarcoma, Embryonal
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Sarcoma processed this record on October 09, 2015