Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01365962
First received: June 1, 2011
Last updated: May 8, 2015
Last verified: May 2015
  Purpose

RATIONALE: 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.

PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.


Condition Intervention
Sarcoma
Genetic: gene expression analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: mass spectrometry

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Study to Assess and Quantify Surface Insulin-like Growth Factor I Receptor (IGF-IR) in Rhabdomyosarcoma (RMS) Tumor Tissue

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Degree of surface IGF-IR expression in RMS tumor tissue [ Designated as safety issue: No ]
  • Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine and quantify the degree of surface insulin-like growth factor I receptor (IGF-IR) expression in rhabdomyosarcoma (RMS) tumor tissue.
  • To assess the feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue.

OUTLINE: Paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor I receptor (IGF-1R) expression by mass spectrometry and correlated with the results obtained by IHC assay.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of rhabdomyosarcoma.

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of rhabdomyosarcoma

    • Alveolar or embryonal rhabdomyosarcoma
  • Available samples from the Cooperative Human Tissue Network (CHTN) bank

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: NCT01365962

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Suman Malempati, MD Doernbecher Children's Hospital at Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01365962     History of Changes
Other Study ID Numbers: ARST11B4, COG-ARST11B4, NCI-2011-02858, ARST11B4
Study First Received: June 1, 2011
Last Updated: May 8, 2015
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 29, 2015