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NCT01365962 Clinical Trial

Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma

Sarcoma Clinical Trial

Official title:
A Study to Assess and Quantify Surface Insulin-like Growth Factor I Receptor (IGF-IR) in Rhabdomyosarcoma (RMS) Tumor Tissue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01365962
Other study ID # ARST11B4
Secondary ID COG-ARST11B4NCI-
Status Completed
Phase N/A
First received June 1, 2011
Last updated May 17, 2016
Start date June 2011

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• gene expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

• mass spectrometry

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of surface IGF-IR expression in RMS tumor tissue No
Primary Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue No
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