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Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

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ClinicalTrials.gov Identifier: NCT01609803
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

May 30, 2012
June 1, 2012
May 18, 2016
June 2012
May 2016   (Final data collection date for primary outcome measure)
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.
Relationship of amplification and fusion status using Fisher's exact test and Freeman-Halton test
Complete list of historical versions of study NCT01609803 on ClinicalTrials.gov Archive Site
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Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma
Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:
tissue samples
Non-Probability Sample
Tissue samples from younger patients with rhabdomyosarcoma from 2006
  • Alveolar Childhood Rhabdomyosarcoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Previously Untreated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma
Other: laboratory biomarker analysis
Correlative studies
Correlative studies
Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.
Intervention: Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
Same as current
May 2016
May 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01609803
ARST12B7
NCI-2012-01972 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST12B7 ( Other Identifier: Children's Oncology Group )
No
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Frederick Barr, MD Children's Oncology Group
Children's Oncology Group
May 2016