Biomarkers in Patients With Advanced Rhabdomyosarcoma

Completed

• Conditions: Childhood Embryonal Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Childhood Alveolar Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma; Stage IV Adult Soft Tissue Sarcoma; Adult Rhabdomyosarcoma
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT01668095
• Lead Sponsor: Children's Oncology Group

Brief Summary

This research trial studies tumor tissue to identify important proteins and biomarkers from patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate whether the expression of a subset of proteins (by immunohistochemistry), known to be Involved in the paired box (Pax)3, Pax7, and Patched-1 neuromuscular development pathways, are dysregulated in advanced and relapsed alveolar and embryonal rhabdomyosarcomas.

OUTLINE:

Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2012-10
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 8 tissue microarrays (TMA) slides of the following diseases available:

  • Alveolar rhabdomyosarcoma
  • Embryonal rhabdomyosarcoma
  • Anaplastic rhabdomyosarcoma

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (biomarker analysis)	Laboratory Biomarker Analysis	Immunohistochemistry is performed for each candidate target (Pax3, Pax7, and Patched-1) in each disease (alveolar, embryonal, and anaplastic rhabdomyosarcoma) for tissue microarray analysis.

Primary Outcome Measures

Name	Time	Method
Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma	1 month

Trial Locations

Locations (1)

Children's Oncology Group; 🇺🇸 Philadelphia, Pennsylvania, United States