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Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01609803
First Posted: June 1, 2012
Last Update Posted: May 18, 2016
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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: 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 ]
    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

Enrollment: 99
Study Start Date: June 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT01609803


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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov 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 Submitted: May 30, 2012
First Posted: June 1, 2012
Last Update Posted: May 18, 2016
Last Verified: May 2016

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