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

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ClinicalTrials.gov Identifier: NCT00899340
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Brief 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.


Condition or disease Intervention/treatment
Head and Neck Cancer Genetic: gene expression analysis Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis

Detailed 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.


Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Protein Expression Profiles in Oropharyngeal Squamous Cell Carcinoma
Study Start Date : May 2006
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Genetic: gene expression analysis
    profiles of HPV(+) and (-) HNSCCs
    Genetic: microarray analysis
    microarray analysis
    Other Name: SAM - significance Analysis of microarrays
    Genetic: protein expression analysis
    protein expression analysis
    Other: immunohistochemistry staining method
    immunohistochemistry staining method
    Other: laboratory biomarker analysis
    laboratory biomarker analysis


Primary Outcome Measures :
  1. Development of biomarkers for early detection or recurrence surveillance [ Time Frame: after 7 months of tissue collection ]
  2. Identification of therapeutic targets and individualization of treatment based on the biology of squamous cell carcinoma of the oropharynx [ Time Frame: after 7months of tissue collection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
community sample
Criteria

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

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): NCT00899340


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center

Responsible Party: Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00899340     History of Changes
Other Study ID Numbers: VICC HN 0624
VU-VICC-HN-0624
VU-VICC-IRB-060380
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
recurrent squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site