Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

This study is currently recruiting participants.
Verified July 2013 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01609803
First received: May 30, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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: 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:

PRIMARY OBJECTIVES:

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.

OUTLINE:

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

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609803

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Frederic G. Barr    301-594-3780    barrfg@mail.nih.gov   
Principal Investigator: Frederic G. Barr         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Frederick Barr Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01609803     History of Changes
Other Study ID Numbers: ARST12B7, NCI-2012-01972, CDR0000734381, COG-ARST12B7
Study First Received: May 30, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 16, 2014