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NCT01609803 Clinical Trial

Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

Recurrent Childhood Rhabdomyosarcoma Clinical Trial

Official title:
Tissue Microarray Studies of the 12q13-q14 Amplicon in Alveolar Rhabdomyosarcoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01609803
Other study ID # ARST12B7
Secondary ID NCI-2012-01972CO
Status Completed
Phase N/A
First received May 30, 2012
Last updated May 16, 2016
Start date June 2012
Est. completion date May 2016

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Alveolar Childhood Rhabdomyosarcoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Previously Untreated Childhood Rhabdomyosarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Rhabdomyosarcoma

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Locations
Country Name City State
United States Children's Oncology Group Monrovia California

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amplification and fusion status as a result of the 12q13-q14 amplification event 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. Baseline No
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