Studying Protein Expression in Tissue Samples From Younger Patients With Rhabdomyosarcoma

Completed

• Conditions: Previously Treated Childhood Rhabdomyosarcoma; Previously Untreated Childhood Rhabdomyosarcoma; Alveolar Childhood Rhabdomyosarcoma; Embryonal Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma
• Interventions: Other: laboratory biomarker analysis

• Registration Number: NCT01609803
• Lead Sponsor: Children's Oncology Group

Brief 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.

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.

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-30
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Correlative studies	laboratory biomarker analysis	Formalin-fixed paraffin-embedded tissue samples are analyzed for 12q13-q14 frequency and protein overexpression by FISH and IHC.

Primary Outcome Measures

Name	Time	Method
Amplification and fusion status as a result of the 12q13-q14 amplification event	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.

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Monrovia, California, United States