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Gene Expression Profiles in Predicting Survival of Patients With Head and Neck Cancer

NCT ID: NCT00897052

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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RATIONALE: Studying samples of tumor 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. It may also help doctors predict survival of patients with head and neck cancer.

PURPOSE: This laboratory study is assessing gene expression profiles in predicting survival of patients with head and neck cancer.

Detailed Description

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OBJECTIVES:

* Identify gene expression profiles associated with survival by DNA microarray assay analysis using RNA from formalin-fixed paraffin-embedded tissue samples from patients with squamous cell carcinoma of the head and neck treated on clinical trial RTOG-9501.

OUTLINE: Formalin-fixed paraffin-embedded tissue samples are analyzed by DNA microarray analysis for gene expression profiling.

Conditions

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Head and Neck Cancer

Keywords

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stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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microarray analysis

Assay RNA obtained from archived formalin fixed paraffin embedded tissue samples

Intervention Type GENETIC

laboratory biomarker analysis

The gene expression data will be linked to the clinical information in order to generate profile of recurrence and survival as a biomarker.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of squamous cell carcinoma of the head and neck, including 1 of the following sites:

* Hypopharynx
* Larynx
* Oral cavity
* Oropharynx
* Stage II-IV disease
* Must have received treatment on clinical trial RTOG-9501
* Formalin-fixed paraffin-embedded tissue samples available

Exclusion Criteria

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Barbara Murphy, MD

Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barbara Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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VU-VICC-HN-0511

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-040509

Identifier Type: -

Identifier Source: secondary_id

VICC HN 0511

Identifier Type: -

Identifier Source: org_study_id