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

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ClinicalTrials.gov Identifier: NCT00897052
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : September 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Head and Neck Cancer Genetic: microarray analysis Other: laboratory biomarker analysis

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Survival Prediction in HNSCC Based on Gene Expression Profiles From FFPE Tissues
Study Start Date : February 2005
Primary Completion Date : December 2007
Study Completion Date : December 2007


Groups and Cohorts

Intervention Details:
    Genetic: microarray analysis
    Assay RNA obtained from archived formalin fixed paraffin embedded tissue samples
    Other: 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.

Outcome Measures

Primary Outcome Measures :
  1. Identification of gene expression profiles used to predict survival as assessed by DNA microarray analysis [ Time Frame: at time of surgical resection ]

Biospecimen Retention:   Samples With DNA
To identify gene expression profile associated with survival from formalin-fixed paraffin embedded tissue samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prior patients who participated on clinical trial RTOG-9501
Criteria

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
Contacts and Locations

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): NCT00897052


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
More Information

Responsible Party: Barbara Murphy, MD, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897052     History of Changes
Other Study ID Numbers: VICC HN 0511
VU-VICC-HN-0511
VU-VICC-IRB-040509
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms