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Protein Expression in Samples From Young Patients With Rhabdomyosarcoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01426945
First received: August 31, 2011
Last updated: May 17, 2016
Last verified: May 2016
  Purpose

RATIONALE: Studying tissue samples 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.

PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.


Condition Intervention
Sarcoma
Genetic: protein expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluating Candidate Protein Expression in Human Rhabdomyosarcoma (RMS)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • RMS protein expression profile [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Tumor tissue

Estimated Enrollment: 77
Study Start Date: November 2011
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To measure the protein expression of candidate proteins in human rhabdomyosarcoma (RMS) tumor samples.

OUTLINE: Archived tumor tissue samples are analyzed for protein expression (i.e., Notch1, Hey1, FGFR4, and Sp1) by IHC techniques and standard commercially available antibodies. Candidate proteins are then correlated with each patient age, gender, rhabdomyosarcoma (RMS) tumor stage, and RMS tumor subtype.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials
Criteria

DISEASE CHARACTERISTICS:

  • Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials

    • Alveolar rhabdomyosarcoma (ARMS)
    • Embryonal rhabdomyosarcoma (ERMS)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426945

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Corinne M. Linardic, MD, PhD Duke Cancer Institute
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01426945     History of Changes
Other Study ID Numbers: ARST11B3  COG-ARST11B3  ARST11B3  NCI-2011-03534 
Study First Received: August 31, 2011
Last Updated: May 17, 2016
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
alveolar childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma

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

ClinicalTrials.gov processed this record on September 29, 2016