Biomarkers in Patients With Advanced Rhabdomyosarcoma

Recurrent Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668095
• Other study ID #: ARST12B8
• Secondary ID: NCI-2012-01997CO
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: May 17, 2016
• Start date: August 2012

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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

• Alveolar rhabdomyosarcoma

• Embryonal rhabdomyosarcoma

• Anaplastic rhabdomyosarcoma

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adult Rhabdomyosarcoma
• Childhood Alveolar Rhabdomyosarcoma
• Childhood Embryonal Rhabdomyosarcoma
• Previously Treated Childhood Rhabdomyosarcoma
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Childhood Rhabdomyosarcoma
• Rhabdomyosarcoma
• Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Philadelphia	Pennsylvania

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	Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma		1 month	No