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Biomarkers in Patients With Advanced Rhabdomyosarcoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668095
First Posted: August 17, 2012
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose
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.

Condition Intervention
Adult Rhabdomyosarcoma Childhood Alveolar Rhabdomyosarcoma Childhood Embryonal Rhabdomyosarcoma Previously Treated Childhood Rhabdomyosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Rhabdomyosarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma Other: Laboratory Biomarker Analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Developmental Pathway Drug-Targets in Advanced Rhabdomyosarcomas

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Prevalence of the candidate target (Pax3, Pax7, or Patched-1), and whether the candidate target is expressed in the tumor vs stroma [ Time Frame: 1 month ]

Biospecimen Retention:   Samples With DNA
tumor tissue

Estimated Enrollment: 10
Study Start Date: August 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ancillary-Correlative (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.
Other: Laboratory Biomarker Analysis
Correlative studies

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rhabdomyosarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment.
Criteria

Inclusion Criteria:

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

    • Alveolar rhabdomyosarcoma
    • Embryonal rhabdomyosarcoma
    • Anaplastic rhabdomyosarcoma
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668095


Locations
United States, Pennsylvania
Children's Oncology Group
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles Keller, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01668095     History of Changes
Other Study ID Numbers: ARST12B8
NCI-2012-01997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARST12B8 ( Other Identifier: Children's Oncology Group )
CDR0000738499 ( Other Identifier: Clinical Trials.gov )
ARST12B8 ( Other Identifier: Children's Oncology Group )
ARST12B8 ( Other Identifier: CTEP )
First Submitted: August 15, 2012
First Posted: August 17, 2012
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Sarcoma
Rhabdomyosarcoma
Rhabdomyosarcoma, Embryonal
Rhabdomyosarcoma, Alveolar
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue