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NCT00899340 Clinical Trial

Protein Expression in Tumor Tissue Samples From Patients With Cancer of the Oropharynx

Head and Neck Cancer Clinical Trial

Official title:
Protein Expression Profiles in Oropharyngeal Squamous Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00899340
Other study ID # VICC HN 0624
Secondary ID VU-VICC-HN-0624V
Status Completed
Phase N/A
First received May 9, 2009
Last updated March 29, 2013
Start date May 2006
Est. completion date March 2008

Study information
Verified date March 2013
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: Studying the proteins expressed in samples of tumor tissue from patients with cancer may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors plan better treatment for patients with cancer of the oropharynx.

PURPOSE: This laboratory study is looking at protein expression in tumor tissue samples from patients with cancer of the oropharynx.

Description:

OBJECTIVES:

- To investigate if some of the differences in gene expression are also reflected at the protein level.

- To determine whether differences in gene expression that are also reflected at the protein level can be used to develop markers for early detection and disease surveillance.

- To identify targets for therapy.

OUTLINE: Archived tumor tissue samples are analyzed for expression of standard immunohistological markers (e.g., p16, p53, and Ki-67) as well as expression of genes identified in a previous gene expression study. Protein expression data are tested for clinical and demographic correlates and compared with gene expression data.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of squamous cell carcinoma of the oropharynx

- Tumor tissue samples available from Vanderbilt Head and Neck Tumor Repository and Vanderbilt Pathology archives

Exclusion Criteria:

- 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
profiles of HPV(+) and (-) HNSCCs
• microarray analysis
microarray analysis
• protein expression analysis
protein expression analysis
Other:
• immunohistochemistry staining method
immunohistochemistry staining method
• laboratory biomarker analysis
laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Development of biomarkers for early detection or recurrence surveillance after 7 months of tissue collection No
Primary Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx after 7months of tissue collection No
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